ELECSYS ANTI-TPO CALSET— 510(k) K103171

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K103171 for ELECSYS ANTI-TPO CALSET, Substantially Equivalent on 2011-02-11. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2010-10-27
Decision date: 2011-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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