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

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

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)

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

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 (

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).

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

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

Device Class : 1

Duns Number: 687910463

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

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