RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01

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 Relion Ultima Blood Glucose Monitoring System, Models 70055-50, Strips (20 Count): 70973-01.

Pre-market Notification Details

• Device ID: K083223
• 510k Number: K083223
• Device Name: RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
• Classification: Glucose Dehydrogenase, Glucose
• 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: LFR
• Subsequent Product Code: JJX
• Subsequent Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-03
• Decision Date: 2009-04-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30681131060319	K083223	000
30681131060302	K083223	000
30681131060296	K083223	000
30681131060289	K083223	000