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) (5) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (5) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (4) Medical device data system (OUG) (2) Lancet, blood (FMK) (1) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (1)

Premarket Exempt

No Yes

Clear

Abbott - 00093815000839 Catalog Number : 70845

Device Description : Abbott Diabetes Care USB Data Cable Software

Device Class :

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

FreeStyle - 00093815704287 Catalog Number : 70428

Device Description : FreeStyle Unistik 2

Device Class :

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

Precision Xtra - 00093815707455 Catalog Number : 70745

Device Description : Precision Xtra Blood ß-Ketone Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 10

Precision Xtra - 00093815707462 Catalog Number : 70746

Device Description : Precision Xtra Blood ß-Ketone Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 10

FreeStyle Lite - 00093815708292 Catalog Number : 70829-70

Device Description : FreeStyle Lite Blood Glucose Monitoring System

Device Class : 2

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

Abbott - 00093815708452 Catalog Number : 70845

Device Description : Abbott Diabetes Care USB Data Cable Software

Device Class : 1

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

FreeStyle Freedom Lite - 00093815709237 Catalog Number : 70923-70

Device Description : FreeStyle Freedom Lite Blood Glucose Monitoring System

Device Class : 2

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

Precision Xceed Pro - 00093815709329 Catalog Number : 70932

Device Description : Precision Xceed Pro Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : JIN, LFR, NBW

Prescription Use : No

Device Count : 100

Precision Xceed Pro - 00093815709350 Catalog Number : 70935

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

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, JIN, LFR

Prescription Use : No

Device Count : 50

OptiumEZ - 00093815710417 Catalog Number : 71041

Device Description : Optium EZ Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, JJX, LFR

Prescription Use : No

Device Count : 50

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