K143534

Substantially Equivalent

Elecsys CA-125 II assay

Applicant: Roche Professional Diagnostics
Product code: LTK
Advisory panel: Immunology
Date received: 2014-12-12
Decision date: 2015-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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