Cleared Traditional

K851518 - MUELLER HINTON SENSITIVITY PLATE

K851518 is an FDA 510(k) clearance for MUELLER HINTON SENSITIVITY PLATE, manufactured by Culture Kits, Inc.. The device is a Class 2 Immunology device with product code JTZ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K851518 · Culture Kits, Inc. · Immunology device
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Apr 1985
Decision
14d
Days
Class 2
Risk

K851518 is an FDA 510(k) clearance for the MUELLER HINTON SENSITIVITY PLATE. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Culture Kits, Inc. (Norwich, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 14 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 Culture Kits, Inc. devices

FDA 510(k) Submission Details - K851518

510(k) Number K851518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date April 29, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 105d · This submission: 14d
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 Immunology devices follow this clearance model.

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

All 45
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K851518.
APL MUELLER HINTON AGAR
K853238 · Apl Medical Supplies · Aug 1985
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291 · Remel Co. · May 1985
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
K851589 · Preferred Micro-Media · Apr 1985
MUELLER HINTON CHOCOLATE AGAR
K850843 · Micro Media Laboratories · Mar 1985
MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOC
K850553 · Hardy Media · Mar 1985
MUELLER-HINTON BROTH
K841560 · Gibco Laboratories Life Technologies, Inc. · May 1984