Cleared Abbreviated

BAYER SPECIAL CHEMISTRY CONTROLS

K033379 · Bayer Diagnostics Corp. · Chemistry
Dec 2003
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K033379 is an FDA 510(k) clearance for the BAYER SPECIAL CHEMISTRY CONTROLS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 19, 2003, 58 days after receiving the submission on October 22, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K033379 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2003
Decision Date December 19, 2003
Days to Decision 58 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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