ABBOTT DIABETES CARE INC

Address:2701 Harbor Bay Parkway,Alameda,CA,94502,US

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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

Glucose dehydrogenase, glucose (LFR) (10) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (10) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE (JQP) (3) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (3) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (2)

Premarket Exempt

No Yes

Clear

OptiumEZ - 00093815710424 Catalog Number : 71042

Device Description : Optium EZ Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW, JJX

Prescription Use : No

Device Count : 100

OptiumEZ - 00093815710653 Catalog Number : 71065

Device Description : Optium EZ Blood Glucose Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR, JJX

Prescription Use : No

Device Count : 1

FreeStyle InsuLinx - 00093815711421 Catalog Number : 71142

Device Description : FreeStyle InsuLinx Blood Glucose Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

FreeStyle InsuLinx - 00093815711438 Catalog Number : 71143

Device Description : FreeStyle InsuLinx Blood Glucose Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

FreeStyle InsuLinx - 00093815711452 Catalog Number : 71145

Device Description : FreeStyle InsuLinx Blood Glucose Monitoring System

Device Class : 2

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

FreeStyle InsuLinx - 00093815711506 Catalog Number : 71150

Device Description : FreeStyle InsuLinx Blood Glucose Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

FreeStyle Precision H - 00093815711810 Catalog Number : 71181

Device Description : FreeStyle Precision H Blood Glucose and Ketone Monitoring System

Device Class : 2

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

FreeStyle Precision Pro - 00093815712848 Catalog Number : 71284

Device Description : FreeStyle Precision Pro Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, JQP, LFR, JIN

Prescription Use : No

Device Count : 100

FreeStyle Precision Pro - 00093815712886 Catalog Number : 71288

Device Description : FreeStyle Precision Pro Blood ß-Ketone Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, JQP, JIN, NBW

Prescription Use : No

Device Count : 50

FreeStyle Precision Pro - 00093815714118 Catalog Number : 71411-70

Device Description : FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, JQP, JIN, NBW

Prescription Use : No

Device Count : 1

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