Cleared Traditional

K962744 - HAEMOPHILUS TEST MEDIUM AGAR (HTM)

K962744 is the FDA 510(k) clearance for HAEMOPHILUS TEST MEDIUM AGAR (HTM) by Prepared Media Laboratory, Inc.. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K962744 · Prepared Media Laboratory, Inc. · Microbiology device
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Oct 1996
Decision
92d
Days
Class 2
Risk

K962744 is an FDA 510(k) clearance for the HAEMOPHILUS TEST MEDIUM AGAR (HTM). Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Prepared Media Laboratory, Inc. (Portland, US). The FDA issued a Cleared decision on October 15, 1996 after a review of 92 days - within the typical 510(k) review window.

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 Prepared Media Laboratory, Inc. devices

Submission Details

510(k) Number K962744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date October 15, 1996
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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 - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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