Cleared Traditional

K840066 - CHOCOLATE AGAR MUELLERH-HINTON BASE

K840066 is the FDA 510(k) clearance for CHOCOLATE AGAR MUELLERH-HINTON BASE by Otisville Biotech, Inc.. It is a Class 2 Microbiology device (product code JTZ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K840066 · Otisville Biotech, Inc. · Microbiology device
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Feb 1984
Decision
35d
Days
Class 2
Risk

K840066 is an FDA 510(k) clearance for the CHOCOLATE AGAR MUELLERH-HINTON BASE. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1984 after a review of 35 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 Otisville Biotech, Inc. devices

Submission Details

510(k) Number K840066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1984
Decision Date February 13, 1984
Days to Decision 35 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
67d faster than avg
Panel avg: 102d · This submission: 35d
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 27
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K840066.
MUELLER-HINTON BROTH
K841560 · Gibco Laboratories Life Technologies, Inc. · May 1984
MUELLER HINTON AGAR W/BLOOD & COFACTOR
K841138 · Anaerobe Systems · Apr 1984
MUELLER HINTON AGAR W/WO BLOOD
K841137 · Anaerobe Systems · Mar 1984
MUELLER-HINTON AGAR PLATE
K834421 · Otisville Biotech, Inc. · Feb 1984
MUELLER HINTON
K830060 · bioMerieux, Inc. · Feb 1983
ACCESSORY MEDIA FOR FLOW TITERTEK MIC
K822119 · Flow Laboratories, Inc. · Aug 1982