OSANG HEALTHCARE Co., Ltd.

Address:132, Anyangcheondong-ro,ANYANG Gyeonggi,KR

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Filters

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

System, Test, Blood Glucose, Over The Counter (NBW) (5) Colorimetric Method, Triglycerides (JGY) (2) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (2)

Premarket Exempt

Clear

OHC COVID-19 Antigen Self Test - 08809115904621 Catalog Number : FBE00608

Device Description : 2 Test Kit / Box

Device Class :

Duns Number: 688195374

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

OHC COVID-19 Antigen Self Test - 08809115904645 Catalog Number : FBE00625

Device Description : 1 Test Kit / Box

Device Class :

Duns Number: 688195374

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

OKRA Pro Glucose monitoring system starter kit - 08809115905352 Catalog Number :

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

OKRA Glucose Test Strip(25T) - 08809115905369 Catalog Number :

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

OKRA Pro Glucose meter - 08809115905376 Catalog Number :

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

CURO L5 Meter - 08809115905406 Catalog Number :

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : CHH, JGY

Prescription Use : No

Device Count : 1

CURO L5 TC test strip - 08809115905413 Catalog Number :

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : CHH

Prescription Use : No

Device Count : 1

CURO L5 TG test strip - 08809115905444 Catalog Number :

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JGY

Prescription Use : No

Device Count : 1

OKRA Glucose Test Strip Refill kit - 08809115905697 Catalog Number :

Device Description : Blood Glucose Test strips Refill kit

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

OKRA Glucose monitoring system starter kit - 08809115905703 Catalog Number :

Device Description : blood glucose monitoring system for self-testing starter kit

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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