NanoEnTek, Inc.

Address:851-14, Seohae-ro, Paltan-myeon,Hwaseong Gyeonggi,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Counter, Differential Cell (GKZ) (3) Radioimmunoassay, Testosterones And Dihydrotestosterone (CDZ) (2) Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers (LTJ) (1) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (1) System, Test, Vitamin D (MRG) (1) Radioimmunoassay, Free Thyroxine (CEC) (1) Fluorometer, For Clinical Use (KHO) (1)

Premarket Exempt

No Yes

Clear

FREND - 08809317540016 Catalog Number : FRTS 025

Device Description : It is used for the quantitative determination of Thyroid Stimulating Hormone in It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 1

FREND - 08809317540153 Catalog Number : FRTE 020

Device Description : It is used for the quantitiative determination of Testosterone in human specimen It is used for the quantitiative determination of Testosterone in human specimen using FREND System.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

FREND - 08809317540184 Catalog Number : FRPS 025

Device Description : It is used for the quantitiative determination of Prostate Specific Antigen(PSA) It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : LTJ

Prescription Use : Yes

Device Count : 1

FREND - 08809317540191 Catalog Number : FRT4 020

Device Description : It is used for the quantitative determination of free thyroxine(free t4) in huma It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : CEC

Prescription Use : Yes

Device Count : 1

FREND - 08809317540207 Catalog Number : F10

Device Description : FREND System is designed for reding the FREND cartridge of a quantitative.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

ADAM - 08809317540252 Catalog Number : ADAM-rWBC device

Device Description : ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

ADAM - 08809317540269 Catalog Number : AD1k-050

Device Description : It is used for the quantitative determination of the residual white blood cell ( It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

ADAM - 08809317540276 Catalog Number : ADAM-rWBC

Device Description : ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in human specimen.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

FREND - 08809317540337 Catalog Number : FRVDAP 020

Device Description : It is used for the quantitative measurement of 25-hydroxy vitamin D and related It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma.

Device Class : 2

Duns Number: 687910463

Premarket Exempt : No

Product Code : MRG

Prescription Use : Yes

Device Count : 1

FREND - 08809317540375 Catalog Number : FRTEAP 020

Device Description : It is used for the quantitative measurement of Total Testosterone in human serum It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample.

Device Class : 1

Duns Number: 687910463

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

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