Cleared Traditional

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B

K041951 · Remel, Inc. · Microbiology
Nov 2004
Decision
118d
Days
Class 1
Risk

About This 510(k) Submission

K041951 is an FDA 510(k) clearance for the XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on November 15, 2004, 118 days after receiving the submission on July 20, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K041951 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2004
Decision Date November 15, 2004
Days to Decision 118 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