Cleared Traditional

XPERT C. DIFFICILE

K091109 · Cepheid · Microbiology
Jul 2009
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K091109 is an FDA 510(k) clearance for the XPERT C. DIFFICILE, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on July 9, 2009, 84 days after receiving the submission on April 16, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K091109 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2009
Decision Date July 09, 2009
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LLH — Reagents, Clostridium Difficile Toxin
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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