XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B— 510(k) K041951

Name: FDA 510(k) clearance K041951
Creator: U.S. Food and Drug Administration
Published: 2004-11-15

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K041951 for XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B, Substantially Equivalent on 2004-11-15. Applicant: Remel, Inc.. Device class: 1.

Clearance details

Applicant: Remel, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2004-07-20
Decision date: 2004-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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