Cleared Traditional

K964487 - IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY T...

K964487 is the FDA 510(k) clearance for IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY T... by Unipath , Ltd.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K964487 · Unipath , Ltd. · Microbiology device
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Feb 1997
Decision
92d
Days
Class 2
Risk

K964487 is an FDA 510(k) clearance for the IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Unipath , Ltd. (Beverly, US). The FDA issued a Cleared decision on February 7, 1997 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 866.1620 - 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 Unipath , Ltd. devices

Submission Details

510(k) Number K964487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1996
Decision Date February 07, 1997
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
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 - JTN Susceptibility Test Discs, Antimicrobial

All 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K964487.
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971635 · Oxoid , Ltd. · Jul 1997
DISPENS-O-DISC (TM) LEVOFLOXACIN
K971120 · Difco Laboratories, Inc. · Apr 1997
DISPENS-O-DISC SPARFLOXACIN
K971211 · Difco Laboratories, Inc. · Apr 1997
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964489 · Unipath , Ltd. · Feb 1997
AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964490 · Unipath , Ltd. · Feb 1997
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964491 · Unipath , Ltd. · Feb 1997