510(k) K053289— COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

Substantially Equivalent

Roche Diagnostics Corp.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LSL
Advisory panel: Microbiology
Date received: 2005-11-25
Decision date: 2006-08-10
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.