GenePOC Carba— 510(k) K190275

Substantially Equivalent

Genepoc, Inc.

FDA 510(k) clearance K190275 for GenePOC Carba, Substantially Equivalent on 2019-05-10. Applicant: Genepoc, Inc.. Device class: 2.

Clearance details

Applicant
Genepoc, Inc.
Product code
Code PMY
Device class
Class 2
Regulation
21 CFR 866.1640
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Quebec, CA
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