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) (8) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (8) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (2) Single (specified) analyte controls (assayed and unassayed) (JJX) (2)

Premarket Exempt

No Yes

Clear

MediSense - 00093815801399 Catalog Number : 80139

Device Description : MediSense Glucose & Ketone Control Solutions

Device Class :

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

MediSense - 00093815803126 Catalog Number : 80312

Device Description : MediSense Glucose & Ketone Control Solutions

Device Class :

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Precision Xtra - 00093815988144 Catalog Number : 98814

Device Description : Precision Xtra Blood Glucose & Ketone Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW, JIN

Prescription Use : No

Device Count : 1

Precision Xtra - 00093815996941 Catalog Number : 99694

Device Description : Precision Xtra Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 100

Precision Xtra - 00093815996958 Catalog Number : 99695

Device Description : Precision Xtra Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 50

Precision Xtra - 00093815997283 Catalog Number : 99728

Device Description : Precision Xtra Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 50

Precision Xtra - 00093815998372 Catalog Number : 99837

Device Description : Precision Xtra Blood Glucose & Ketone Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR, JIN

Prescription Use : No

Device Count : 1

Precision Xtra - 00093815998389 Catalog Number : 99838

Device Description : Precision Xtra Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 50

Precision Xtra - 00093815998778 Catalog Number : 99877

Device Description : Precision Xtra Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 100

Precision Xtra - 00093815998785 Catalog Number : 99878

Device Description : Precision Xtra Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 100

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