K162772

Substantially Equivalent

ARIES GBS Assay

Applicant: Luminex Corporation
Product code: NJR
Advisory panel: Microbiology
Date received: 2016-10-03
Decision date: 2016-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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