MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY— 510(k) K043318

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K043318 for MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY, Substantially Equivalent on 2004-12-23. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: 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.