Cleared Abbreviated

BAYER SPECIAL CHEMISTRY CALIBRATORS

K033380 · Bayer Diagnostics Corp. · Chemistry
Dec 2003
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K033380 is an FDA 510(k) clearance for the BAYER SPECIAL CHEMISTRY CALIBRATORS, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 16, 2003, 55 days after receiving the submission on October 22, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K033380 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2003
Decision Date December 16, 2003
Days to Decision 55 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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