Cleared Traditional

DRYSLIDE COAGULASE

K950706 · Difco Laboratories, Inc. · Microbiology
May 1995
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K950706 is an FDA 510(k) clearance for the DRYSLIDE COAGULASE, a Plasma, Coagulase, Human, Horse And Rabbit (Class I — General Controls, product code JTL), submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on May 16, 1995, 90 days after receiving the submission on February 15, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2160.

Submission Details

510(k) Number K950706 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1995
Decision Date May 16, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTL — Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2160

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