Cleared Traditional

K933657 - REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILI...

K933657 is the FDA 510(k) clearance for REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILI... by Remel Co.. It is a Class 2 Microbiology device (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

Submission Details

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.

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 K933657.
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
K944275 · Difco Laboratories, Inc. · Dec 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