Cleared Traditional

K930702 - DRYSLIDE CEFIN

K930702 is an FDA 510(k) clearance for DRYSLIDE CEFIN, manufactured by Difco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K930702 · Difco Laboratories, Inc. · Microbiology device
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Dec 1993
Decision
315d
Days
Class 2
Risk

K930702 is an FDA 510(k) clearance for the DRYSLIDE CEFIN. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on December 22, 1993 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K930702

510(k) Number K930702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date December 22, 1993
Days to Decision 315 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 102d · This submission: 315d
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 K930702.
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K935975 · Remel, Inc. · Sep 1994
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K940359 · Becton Dickinson Microbiology Systems · Mar 1994
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK
K934100 · Remel Co. · Nov 1993
REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK
K933657 · Remel Co. · Oct 1993
REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK
K933118 · Remel Co. · Aug 1993