ELECSYS CORTISOL TEST SYSTEM— 510(k) K021218

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K021218 for ELECSYS CORTISOL TEST SYSTEM, Substantially Equivalent on 2002-09-09. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JFT
Advisory panel: Clinical Chemistry
Date received: 2002-04-17
Decision date: 2002-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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