Cleared Traditional

K800979 - MUELLER HINTIN AGAR W/5% SHEEP BLOOD

K800979 is the FDA 510(k) clearance for MUELLER HINTIN AGAR W/5% SHEEP BLOOD by Quality Assurance Laboratory, Inc.. It is a Class 2 Microbiology device (product code JTZ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K800979 · Quality Assurance Laboratory, Inc. · Microbiology device
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May 1980
Decision
30d
Days
Class 2
Risk

K800979 is an FDA 510(k) clearance for the MUELLER HINTIN AGAR W/5% SHEEP BLOOD. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Quality Assurance Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1980 after a review of 30 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 Quality Assurance Laboratory, Inc. devices

Submission Details

510(k) Number K800979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1980
Decision Date May 23, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
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 29
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K800979.
MUELLER HINTON AGAR
K811049 · Acumedia Manufacturers, Inc. · Apr 1981
MUELLER HINTON BROTH
K802957 · Gibco Laboratories Life Technologies, Inc. · Dec 1980
MUELLER HINTON AGAR
K802498 · Oxoid U.S.A., Inc. · Nov 1980
MUELLER HINTON CHOCOLATE
K791815 · Isle Media and Sterile Products, Inc. · Oct 1979
MUELLER HINTON MEDIUM W/SHEEP BLOOD
K791818 · Isle Media and Sterile Products, Inc. · Oct 1979
MUELLER-HINTON AGAR
K791624 · American Laboratory Supply, Inc. · Sep 1979