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) (7) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (3) Glucose Oxidase, Glucose (CGA) (1)

Premarket Exempt

Clear

OKRA Glucose Test Strip - 08809115905710 Catalog Number :

Device Description : Blood Glucose Test strips

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

OKRA Glucose meter - 08809115905727 Catalog Number :

Device Description : blood glucose monitoring system for self-testing meter

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Oh'care Lite Smart Glucose Test Strip - 08809115905796 Catalog Number :

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Oh'care Lite Smart Glucose Meter - 08809115905802 Catalog Number :

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Oh'Care Lite Smart Glucose control solution-Level 1 - 08809115906519 Catalog Number :

Device Description : blood glucose meter and test strip control solution level 1

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Oh'Care Lite Smart Glucose control solution-Level 2 - 08809115906526 Catalog Number :

Device Description : blood glucose meter and test strip control solution-Level 2

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Oh'Care Lite Smart Glucose control solution-Level 3 - 08809115906533 Catalog Number :

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

Device Class : 1

Duns Number: 688195374

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Oh'Care Lite Smart Glucose Test Strip - 08809115906540 Catalog Number :

Device Description : blood glucose test strip

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Oh'Care Lite Smart Glucose monitoring system - 08809115906557 Catalog Number :

Device Description : blood glucose monitoring system for self-testing

Device Class : 2

Duns Number: 688195374

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Element™ Test Strips - 08809115908438 Catalog Number :

Device Description : Blood Glucose Monitoring System

Device Class :

Duns Number: 688195374

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

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