K151529

Substantially Equivalent

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: CDZ
Advisory panel: Clinical Chemistry
Date received: 2015-06-08
Decision date: 2016-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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