ELECSYS DHEA-S CALSET— 510(k) K002760

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K002760 for ELECSYS DHEA-S CALSET, Substantially Equivalent on 2000-10-05. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIS
Advisory panel: Clinical Chemistry
Date received: 2000-09-05
Decision date: 2000-10-05
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.