Cleared Abbreviated

BAYER LIGAND PLUS 1, 2, 3 CONTROLS

K030452 · Bayer Diagnostics Corp. · Chemistry
Mar 2003
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K030452 is an FDA 510(k) clearance for the BAYER LIGAND PLUS 1, 2, 3 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 March 3, 2003, 20 days after receiving the submission on February 11, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K030452 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2003
Decision Date March 03, 2003
Days to Decision 20 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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