Cleared Traditional

PROGASTRO CD ASSAY

K090239 · Prodesse, Inc. · Microbiology
Apr 2009
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K090239 is an FDA 510(k) clearance for the PROGASTRO CD ASSAY, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on April 16, 2009, 73 days after receiving the submission on February 2, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K090239 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2009
Decision Date April 16, 2009
Days to Decision 73 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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