PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY— 510(k) K033479

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K033479 for PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY, Substantially Equivalent on 2004-02-26. Applicant: Remel, Inc..

Clearance details

Applicant: Remel, Inc.
Product code: Code LLH
Advisory panel: Microbiology
Date received: 2003-11-03
Decision date: 2004-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramsey, MN, US

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