THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS

Glucose Dehydrogenase, Glucose

ABBOTT DIABETES CARE INC.

The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for The Precision / Optium Point Of Care Blood Glucose Test Strips.

Pre-market Notification Details

• Device ID: K070984
• 510k Number: K070984
• Device Name: THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
• Classification: Glucose Dehydrogenase, Glucose
• Applicant: ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502
• Contact: Maria E Trejo
• Correspondent: Maria E Trejo; ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502
• Product Code: LFR
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-04-06
• Decision Date: 2007-11-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30093815801161	K070984	000
30093815711811	K070984	000