Cleared Traditional

OSOM C. DIFFICILE TOXIN A/B TEST

K102242 · Genzyme Corporation · Microbiology
Dec 2010
Decision
134d
Days
Class 1
Risk

About This 510(k) Submission

K102242 is an FDA 510(k) clearance for the OSOM C. DIFFICILE TOXIN A/B TEST, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Genzyme Corporation (Framingham, US). The FDA issued a Cleared decision on December 21, 2010, 134 days after receiving the submission on August 9, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K102242 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2010
Decision Date December 21, 2010
Days to Decision 134 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