C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96— 510(k) K032897

Name: FDA 510(k) clearance K032897
Creator: U.S. Food and Drug Administration
Published: 2004-05-27

Substantially Equivalent

Ivd Research, Inc.

FDA 510(k) clearance K032897 for C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96, Substantially Equivalent on 2004-05-27. Applicant: Ivd Research, Inc.. Device class: 1.

Clearance details

Applicant: Ivd Research, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2003-09-17
Decision date: 2004-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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