ELECYSYS SHBG— 510(k) K102814

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K102814 for ELECYSYS SHBG, Substantially Equivalent on 2011-01-20. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 2010-09-28
Decision date: 2011-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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