Cleared Traditional

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

K033479 · Remel, Inc. · Microbiology

Feb 2004

Decision

115d

Days

Class 1

Risk

About This 510(k) Submission

K033479 is an FDA 510(k) clearance for the PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Remel, Inc. (Ramsey, US). The FDA issued a Cleared decision on February 26, 2004, 115 days after receiving the submission on November 3, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K033479 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2003
Decision Date	February 26, 2004
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF