FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23

System, Test, Blood Glucose, Over The Counter

ABBOTT DIABETES CARE INC.

The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Blood Glucose Test Strips, Models 100-count: 12401-01, 12101-21, 12101-22, 12101-23.

Pre-market Notification Details

• Device ID: K092638
• 510k Number: K092638
• Device Name: FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502
• Contact: Arul Sterlin
• Correspondent: Arul Sterlin; ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-27
• Decision Date: 2010-06-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30699073707926	K092638	000
30699073124501	K092638	000
30699073124013	K092638	000
40699073121019	K092638	000
40699073120500	K092638	000