EntericBio Dx Assay— 510(k) K182703

Substantially Equivalent

Serosep , Ltd.

FDA 510(k) clearance K182703 for EntericBio Dx Assay, Substantially Equivalent on 2019-06-19. Applicant: Serosep , Ltd..

Clearance details

Applicant: Serosep , Ltd.
Product code: Code PCH
Advisory panel: Microbiology
Date received: 2018-09-27
Decision date: 2019-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annacotty, IE

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