ABBOTT DIABETES CARE INC

Address:1360 SOUTH LOOP RD.,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) (9) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (9) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (2) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE (JQP) (1) Continuous glucose monitor retrospective data analysis software (PHV) (1)

Premarket Exempt

No Yes

Clear

FreeStyle Precision Pro - 00093815714125 Catalog Number : 71412-70

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

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, JIN, JQP, NBW

Prescription Use : No

Device Count : 1

FreeStyle InsuLinx - 00093815715009 Catalog Number : 71500

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

Precision Xtra - 00093815715023 Catalog Number : 71502

Device Description : Precision Xtra Blood Glucose & Ketone Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, JIN, LFR

Prescription Use : No

Device Count : 1

FreeStyle Precision Neo - 00093815715771 Catalog Number : 71577

Device Description : FreeStyle Precision Neo Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 25

FreeStyle Precision Neo - 00093815715795 Catalog Number : 71579

Device Description : FreeStyle Precision Neo Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 50

FreeStyle Precision Neo - 00093815715818 Catalog Number : 71581

Device Description : FreeStyle Precision Neo Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 100

FreeStyle Libre Pro - 00093815751700 Catalog Number : 75170

Device Description : FreeStyle Libre Pro Software

Device Class : 1

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : Yes

Device Count : 1

FreeStyle Precision Neo - 00093815751755 Catalog Number : 75175

Device Description : FreeStyle Precision Neo Blood Glucose Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

Precision Xtra - 00093815800507 Catalog Number : 80050

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 : 10

FreeStyle Precision H - 00093815801160 Catalog Number : 80116

Device Description : FreeStyle Precision H Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 100

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