OSANG HEALTHCARE Co., Ltd.

Address:132, Anyangcheondong-ro,ANYANG 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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (5) Glucose Dehydrogenase, Glucose (LFR) (3) System, Test, Blood Glucose, Over The Counter (NBW) (3) Colorimetric Method, Triglycerides (JGY) (2) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (2) Glucose Oxidase, Glucose (CGA) (2)

Premarket Exempt

Clear

AimStrip Tandem Lipid Profile and glucose measuring system - 00695684773014 Catalog Number :

Device Description : Lipid and Glucose Measuring System

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : CGA, JJX, CHH, JGY

Prescription Use : Yes

Device Count : 1

AimStrip Tandem Total Cholesterol Test Strips - 00695684773106 Catalog Number :

Device Description : Total Cholestesol test strip

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : CHH

Prescription Use : Yes

Device Count : 1

AimStrip Tandem Total Cholesterol Control Solution - 00695684773120 Catalog Number :

Device Description : Lipid measuring meter and Total Cholesterol test strip control solution level 1,2

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

AimStrip Tandem Total Triglycerides Test Strips - 00695684774103 Catalog Number :

Device Description : Triglycerides test strip

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JGY

Prescription Use : Yes

Device Count : 1

AimStrip Tandem Total Triglycerides Control Solution - 00695684774127 Catalog Number :

Device Description : Lipid measuring meter and Triglycerides test strip control solution level 1,2

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

AimStrip Tandem Glucose control solution - 00695684775124 Catalog Number :

Device Description : blood glucose meter and test strip control solution-level 1,2,3

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

AimStrip Tandem blood glucose test strips - 00695684775506 Catalog Number :

Device Description : AimStrip Tandem blood glucose test strips

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 1

Oh’Care Lite Blood Glucose Monitoring System Kit - 00793150629763 Catalog Number :

Device Description : Blood Glucose Monitoring System Kit

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JJX, NBW, LFR

Prescription Use : No

Device Count : 1

Oh’Care Lite Blood Glucose Monitoring System for Self-Testing - 00793150629770 Catalog Number : INFM003L

Device Description : Blood Glucose Monitoring System for Self-Testing

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

Oh’Care Lite Blood Glucose Test strips - 00793150629787 Catalog Number : INFS003L

Device Description : Blood Glucose Test strips

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

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