ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE— 510(k) K043175

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K043175 for ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE, Substantially Equivalent on 2004-11-24. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code NHG
Advisory panel: Clinical Chemistry
Date received: 2004-11-16
Decision date: 2004-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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