Cleared Traditional

K933657 - REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK

K933657 is an FDA 510(k) clearance for REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILI..., manufactured by Remel Co.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K933657 · Remel Co. · Microbiology device
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Oct 1993
Decision
93d
Days
Class 2
Risk

K933657 is an FDA 510(k) clearance for the REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on October 28, 1993 after a review of 93 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 Remel Co. devices

FDA 510(k) Submission Details - K933657

510(k) Number K933657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date October 28, 1993
Days to Decision 93 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
9d faster than avg
Panel avg: 102d · This submission: 93d
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 323
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K933657.
PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC
K940359 · Becton Dickinson Microbiology Systems · Mar 1994
DRYSLIDE CEFIN
K930702 · Difco Laboratories, Inc. · Dec 1993
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK
K934100 · Remel Co. · Nov 1993
REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK
K933118 · Remel Co. · Aug 1993
REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK
K931799 · Remel Co. · Jun 1993
REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK
K931289 · Remel Co. · Jun 1993