Cleared Traditional

C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96

K032897 · Ivd Research, Inc. · Microbiology

May 2004

Decision

253d

Days

Class 1

Risk

About This 510(k) Submission

K032897 is an FDA 510(k) clearance for the C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Ivd Research, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 27, 2004, 253 days after receiving the submission on September 17, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K032897 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2003
Decision Date	May 27, 2004
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement