ELECSYS SHBG IMMUNOASSAY— 510(k) K031717

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K031717 for ELECSYS SHBG IMMUNOASSAY, Substantially Equivalent on 2003-08-05. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 2003-06-03
Decision date: 2003-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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