Cleared Traditional

K850843 - MUELLER HINTON CHOCOLATE AGAR

K850843 is an FDA 510(k) clearance for MUELLER HINTON CHOCOLATE AGAR, manufactured by Micro Media Laboratories. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K850843 · Micro Media Laboratories · Microbiology device
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Mar 1985
Decision
19d
Days
Class 2
Risk

K850843 is an FDA 510(k) clearance for the MUELLER HINTON CHOCOLATE AGAR. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on March 20, 1985 after a review of 19 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.

FDA 510(k) Submission Details - K850843

510(k) Number K850843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date March 20, 1985
Days to Decision 19 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
83d faster than avg
Panel avg: 102d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTZ Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K850843.
MUELLER HINTON SENSITIVITY PLATE
K851518 · Culture Kits, Inc. · Apr 1985
MUELLER HINTON AGAR
K850715 · Rapid City Regional Hospital, Inc. · Mar 1985
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING
K850731 · Roseville Medical Laboratoriesu · Mar 1985
MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOC
K850553 · Hardy Media · Mar 1985
SLT 220 WASHER FOR MICROITITERPLATES
K844892 · Slt Labinstruments, Inc. · Feb 1985
MUELLER HINTON BROTH
K842854 · Anarobe Systems · Aug 1984
K850843 · MUELLER HINTON CHOCOLATE AGAR
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