Cleared Traditional

K820792 - #19041-150X15MM MUELLER HINTON

K820792 is the FDA 510(k) clearance for #19041-150X15MM MUELLER HINTON by Biomedica, Inc.. It is a Class 2 Microbiology device (product code JTZ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K820792 · Biomedica, Inc. · Microbiology device
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Apr 1982
Decision
16d
Days
Class 2
Risk

K820792 is an FDA 510(k) clearance for the #19041-150X15MM MUELLER HINTON. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Biomedica, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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 Biomedica, Inc. devices

Submission Details

510(k) Number K820792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date April 08, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

All 28
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K820792.
MUELLER HINTON
K830060 · bioMerieux, Inc. · Feb 1983
ACCESSORY MEDIA FOR FLOW TITERTEK MIC
K822119 · Flow Laboratories, Inc. · Aug 1982
MUELLER HINTON W/5% SHEEP'S BLOOD
K821607 · Hardy Media · Jul 1982
MUELLER HINTON AGAR
K811646 · Hardy Media · Jul 1981
MUELLER-HINTON
K811608 · Micro Media Laboratories · Jun 1981
MUELLER HINTON BROTH
K811136 · Acumedia Manufacturers, Inc. · May 1981