ARCHITECT CORTISOL ASSAY— 510(k) K062204

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K062204 for ARCHITECT CORTISOL ASSAY, Substantially Equivalent on 2006-09-22. Applicant: Seradyn, Inc..

Clearance details

Applicant: Seradyn, Inc.
Product code: Code JFT
Advisory panel: Clinical Chemistry
Date received: 2006-08-01
Decision date: 2006-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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