Cleared Special

K083223 - RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
(FDA 510(k) Clearance)

K083223 · Abbott Diabetes Care, Inc. · Chemistry

Apr 2009

Decision

164d

Days

Class 2

Risk

K083223 is an FDA 510(k) clearance for the RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on April 16, 2009, 164 days after receiving the submission on November 3, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K083223 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2008
Decision Date	April 16, 2009
Days to Decision	164 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF