Cleared Traditional

K871093 - CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL...

K871093 is the FDA 510(k) clearance for CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL... by bioMerieux, Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K871093 · bioMerieux, Inc. · Microbiology device
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Apr 1987
Decision
16d
Days
Class 1
Risk

K871093 is an FDA 510(k) clearance for the CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR). Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on April 3, 1987 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number K871093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date April 03, 1987
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 239
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