ELECSYS PRECICONTROL BONE— 510(k) K051543

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K051543 for ELECSYS PRECICONTROL BONE, Substantially Equivalent on 2005-10-17. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2005-06-10
Decision date: 2005-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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