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

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..

Clearance details

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

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