Cepheid Xpert C. difficile/Epi Control Panel— 510(k) K190463

Substantially Equivalent

Microbiologics, Inc.

FDA 510(k) clearance K190463 for Cepheid Xpert C. difficile/Epi Control Panel, Substantially Equivalent on 2019-04-19. Applicant: Microbiologics, Inc..

Clearance details

Applicant: Microbiologics, Inc.
Product code: Code PMN
Advisory panel: Microbiology
Date received: 2019-02-26
Decision date: 2019-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Cloud, MN, US

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