Cleared Traditional

K930702 - DRYSLIDE CEFIN

K930702 is the FDA 510(k) clearance for DRYSLIDE CEFIN by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (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

Submission Details

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.

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 K930702.
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1996
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · Remel Co. · Feb 1996
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
K944275 · Difco Laboratories, Inc. · Dec 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