ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3— 510(k) K132828

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K132828 for ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3, Substantially Equivalent on 2013-12-04. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JKR
Advisory panel: Clinical Chemistry
Date received: 2013-09-09
Decision date: 2013-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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