K170557

Substantially Equivalent

GenePOC GBS LB

Applicant: Genepoc, Inc.
Product code: NJR
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 ↗

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