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.. Device class: 2.

Clearance details

Applicant: Serosep , Ltd.
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2018-09-27
Decision date: 2019-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annacotty, IE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.