Cleared Abbreviated

ADVIA CHEMISTRY MICROALBUMIN CONTROLS

K052242 · Bayer Healthcare, LLC · Chemistry
Oct 2005
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K052242 is an FDA 510(k) clearance for the ADVIA CHEMISTRY MICROALBUMIN CONTROLS, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on October 3, 2005, 47 days after receiving the submission on August 17, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K052242 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2005
Decision Date October 03, 2005
Days to Decision 47 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJW — Urinalysis Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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