Cleared Abbreviated

K033379 - BAYER SPECIAL CHEMISTRY CONTROLS

K033379 is the FDA 510(k) clearance for BAYER SPECIAL CHEMISTRY CONTROLS by Bayer Diagnostics Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Abbreviated 510(k) pathway after a 58-day FDA review.

K033379 · Bayer Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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Dec 2003
Decision
58d
Days
Class 1
Risk

K033379 is an FDA 510(k) clearance for the BAYER SPECIAL CHEMISTRY CONTROLS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bayer Diagnostics Corp. devices

Submission Details

510(k) Number K033379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 464
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