Cleared Traditional

ADVIA IMS GLUCOSE ASSAY

K052163 · Bayer Healthcare, LLC · Chemistry
Oct 2005
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K052163 is an FDA 510(k) clearance for the ADVIA IMS GLUCOSE ASSAY, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on October 11, 2005, 63 days after receiving the submission on August 9, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K052163 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2005
Decision Date October 11, 2005
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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