Cleared Traditional

K930702 - DRYSLIDE CEFIN
(FDA 510(k) Clearance)

Dec 1993
Decision
315d
Days
Class 2
Risk

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

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on December 22, 1993, 315 days after receiving the submission on February 10, 1993.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1620.

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

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.1620

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