Cleared Traditional

K941579 - MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)

K941579 is an FDA 510(k) clearance for MODIFIED MICRO TEST MULTI MICROBE MEDIU..., manufactured by Microtest. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K941579 · Microtest · Microbiology device
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Oct 1994
Decision
203d
Days
Class 1
Risk

K941579 is an FDA 510(k) clearance for the MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5). Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Microtest (Snelleville, US). The FDA issued a Cleared decision on October 21, 1994 after a review of 203 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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.

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FDA 510(k) Submission Details - K941579

510(k) Number K941579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1994
Decision Date October 21, 1994
Days to Decision 203 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
101d slower than avg
Panel avg: 102d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 78
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K941579.
10B ARGININE BROTH
K961046 · Remel, L.P. · Sep 1996
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K962843 · Starplex Scientific, Inc. · Sep 1996
CVM TRANSPORT
K955451 · Hardy Diagnostics · Jul 1996
FLEXTRANS
K935987 · Baxter Diagnostics, Inc. · Aug 1994
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
BACTI-SWAB
K910180 · Remel Co. · May 1991