Cleared Traditional

K896332 - SUPPLEMENT TO ANAEROBIC MIC PANEL

K896332 is the FDA 510(k) clearance for SUPPLEMENT TO ANAEROBIC MIC PANEL by Microtech Medical Systems, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K896332 · Microtech Medical Systems, Inc. · Microbiology device
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Feb 1990
Decision
95d
Days
Class 2
Risk

K896332 is an FDA 510(k) clearance for the SUPPLEMENT TO ANAEROBIC MIC PANEL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Microtech Medical Systems, Inc. (Aurora, US). The FDA issued a Cleared decision on February 5, 1990 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Microtech Medical Systems, Inc. devices

Submission Details

510(k) Number K896332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1989
Decision Date February 05, 1990
Days to Decision 95 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 102d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 365
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K896332.
PASCO MIC AND MIC/ID MODIFIED
K902739 · Pasco Laboratories, Inc. · Jul 1990
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
K896278 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
K896566 · Medical Specialties, Inc. · Feb 1990
PASCO MIC/ID GRAM-POSITIVE PANEL
K895215 · Difco Laboratories, Inc. · Jan 1990
API UNISCEPT KB
K895796 · Analytical Products, Inc. · Nov 1989
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
K894189 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989