K160724

Substantially Equivalent

ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: CGS
Advisory panel: Clinical Chemistry
Date received: 2016-03-16
Decision date: 2016-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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