Cleared Traditional

K830060 - MUELLER HINTON

K830060 is the FDA 510(k) clearance for MUELLER HINTON by bioMerieux, Inc.. It is a Class 2 Immunology device (product code JTZ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K830060 · bioMerieux, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1983
Decision
29d
Days
Class 2
Risk

K830060 is an FDA 510(k) clearance for the MUELLER HINTON. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.1700 - the FDA immunology 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 K830060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date February 09, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
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 Immunology devices follow this clearance model.

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

All 25
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K830060.
MUELLER HINTON AGAR W/WO BLOOD
K841137 · Anaerobe Systems · Mar 1984
CHOCOLATE AGAR MUELLERH-HINTON BASE
K840066 · Otisville Biotech, Inc. · Feb 1984
MUELLER-HINTON AGAR PLATE
K834421 · Otisville Biotech, Inc. · Feb 1984
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