Cleared Traditional

K964421 - REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK

K964421 is an FDA 510(k) clearance for REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK, manufactured by Remel, L.P.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K964421 · Remel, L.P. · Microbiology device
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Dec 1996
Decision
66d
Days
Class 2
Risk

K964421 is an FDA 510(k) clearance for the REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on December 6, 1996 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Remel, L.P. devices

FDA 510(k) Submission Details - K964421

510(k) Number K964421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1996
Decision Date December 06, 1996
Days to Decision 66 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
36d faster than avg
Panel avg: 102d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTN Device Classification - Class 2, Special Controls

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 314
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K964421.
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964501 · Unipath , Ltd. · Feb 1997
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964512 · Unipath , Ltd. · Feb 1997
CETIBUTEN, 30MCG, SENSI-DISC
K965159 · Becton Dickinson Microbiology Systems · Feb 1997
MEROPENEM, 10 MCG, SENSI-DISC
K963845 · Becton Dickinson Microbiology Systems · Oct 1996
DISPENS-O-DISC MEROPENEM
K963508 · Difco Laboratories, Inc. · Sep 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1996