Cleared Traditional

K960313 - MUELLER HINTON AGAR WITH 2% NACI

K960313 is an FDA 510(k) clearance for MUELLER HINTON AGAR WITH 2% NACI, manufactured by Remel, L.P.. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K960313 · Remel, L.P. · Microbiology device
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Mar 1996
Decision
63d
Days
Class 2
Risk

K960313 is an FDA 510(k) clearance for the MUELLER HINTON AGAR WITH 2% NACI. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on March 25, 1996 after a review of 63 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 Remel, L.P. devices

FDA 510(k) Submission Details - K960313

510(k) Number K960313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date March 25, 1996
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
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 31
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K960313.
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K963036 · Becton Dickinson Microbiology Systems · Oct 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420 · Becton Dickinson Microbiology Systems · Apr 1996
MUELLER HINTON AGAR W/OXACILLIN
K941985 · Carr-Scarborough Microbiologicals, Inc. · Aug 1994
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
K882351 · Lakewood Biochemical Co., Inc. · Jun 1988
MULLER HINTON BROTH
K880105 · Hardy Media · Mar 1988
MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)
K870649 · Hardy Media · Apr 1987