Cleared Traditional

CLEARVIEW C. DIFF A

K955067 · Unipath , Ltd. · Microbiology
Sep 1996
Decision
312d
Days
Class 1
Risk

About This 510(k) Submission

K955067 is an FDA 510(k) clearance for the CLEARVIEW C. DIFF A, a Antigen, C. Difficile (Class I — General Controls, product code MCB), submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on September 13, 1996, 312 days after receiving the submission on November 6, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K955067 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1995
Decision Date September 13, 1996
Days to Decision 312 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MCB — Antigen, C. Difficile
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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