ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR— 510(k) K122599

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K122599 for ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR, Substantially Equivalent on 2012-10-03. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code DDR
Advisory panel: Immunology
Date received: 2012-08-27
Decision date: 2012-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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