K043318

Substantially Equivalent

MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY

Applicant: Roche Diagnostics Corp.
Product code: CGN
Advisory panel: Clinical Chemistry
Date received: 2004-12-02
Decision date: 2004-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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