GenePOC GBS LB— 510(k) K170557

Substantially Equivalent

Genepoc, Inc.

FDA 510(k) clearance K170557 for GenePOC GBS LB, Substantially Equivalent on 2017-05-25. Applicant: Genepoc, Inc.. Device class: 1.

Clearance details

Applicant: Genepoc, Inc.
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2017-02-24
Decision date: 2017-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

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