Cleared Traditional

K844547 - TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE

K844547 is the FDA 510(k) clearance for TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE by bioMerieux, Inc.. It is a Class 1 Microbiology device (product code JSD) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K844547 · bioMerieux, Inc. · Microbiology device
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Jan 1985
Decision
56d
Days
Class 1
Risk

K844547 is an FDA 510(k) clearance for the TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE. Classified as Culture Media, Selective Broth (product code JSD), Class I - General Controls.

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on January 16, 1985 after a review of 56 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 K844547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date January 16, 1985
Days to Decision 56 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
46d faster than avg
Panel avg: 102d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSD Culture Media, Selective Broth
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 - JSD Culture Media, Selective Broth

All 20
Devices cleared under the same product code (JSD) and FDA review panel - the closest regulatory comparables to K844547.
TODD HEWITT W/CNA (LIM BROTH)
K871447 · Remel Co. · May 1987
ALKALINE PEPTONE WATER
K871640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
T9802 TSB W/6.5% NACL
K870594 · Lakewood Biochemical Co., Inc. · Mar 1987
SF BROTH
K834013 · Micro Media Laboratories · Dec 1983
SELENITE BROTH
K834015 · Micro Media Laboratories · Dec 1983
GROUP STREP BROTH T3472 LIM
K833759 · Gibco Laboratories Life Technologies, Inc. · Dec 1983