K142156

Substantially Equivalent

SEEGENE ANYPLEX II HSV-1/2 ASSAY

Applicant: Seegene
Product code: OQO
Advisory panel: Microbiology
Date received: 2014-08-06
Decision date: 2015-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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