ELECSYS CA 125 II CALSET— 510(k) K003969

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003969 for ELECSYS CA 125 II CALSET, Substantially Equivalent on 2001-01-12. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIS
Advisory panel: Clinical Chemistry
Date received: 2000-12-22
Decision date: 2001-01-12
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.