Cleared Traditional

K864248 - MUELLER HINTON AGAR - SUPPLEMENTED

K864248 is an FDA 510(k) clearance for MUELLER HINTON AGAR - SUPPLEMENTED, manufactured by Mds Laboratories, Inc.. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K864248 · Mds Laboratories, Inc. · Microbiology device
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Mar 1987
Decision
154d
Days
Class 2
Risk

K864248 is an FDA 510(k) clearance for the MUELLER HINTON AGAR - SUPPLEMENTED. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987 after a review of 154 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mds Laboratories, Inc. devices

FDA 510(k) Submission Details - K864248

510(k) Number K864248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 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
52d slower than avg
Panel avg: 102d · This submission: 154d
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 44
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K864248.
MUELLER HINTON AGAR SMALL
K864245 · Mds Laboratories, Inc. · Mar 1987
MUELLER HINTON AGAR LARGE
K864246 · Mds Laboratories, Inc. · Mar 1987
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K864247 · Mds Laboratories, Inc. · Mar 1987
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · Gibco Laboratories Life Technologies, Inc. · Oct 1986
APL MUELLER HINTON AGAR
K853238 · Apl Medical Supplies · Aug 1985
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291 · Remel Co. · May 1985