Cleared Traditional

K844538 - COOKED MEAT MEDIUM

K844538 is the FDA 510(k) clearance for COOKED MEAT MEDIUM by bioMerieux, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K844538 · bioMerieux, Inc. · Microbiology device
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Jan 1985
Decision
47d
Days
Class 1
Risk

K844538 is an FDA 510(k) clearance for the COOKED MEAT MEDIUM. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on January 7, 1985 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 K844538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date January 07, 1985
Days to Decision 47 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
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K844538.
BRAIN HEART INFUSION BROTH
K844529 · bioMerieux, Inc. · Jan 1985
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TRYPTIC SOY BROTH
K844541 · bioMerieux, Inc. · Jan 1985
BIOTIS SCHAEDLER AGAR & BROTH
K843764 · Otisville Biotech, Inc. · Oct 1984
MAXIMUM RECOVERY DILUENT
K841662 · Oxoid U.S.A., Inc. · Jun 1984