Elecsys T-Uptake Calset— 510(k) K143342

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K143342 for Elecsys T-Uptake Calset, Substantially Equivalent on 2014-12-19. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2014-11-21
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indanapolis, IL, US

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