Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)— 510(k) K150168

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K150168 for Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL), Substantially Equivalent on 2015-11-04. Applicant: Siemens Healthcare Diagnostics.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code MLM
Advisory panel: Clinical Chemistry
Date received: 2015-01-26
Decision date: 2015-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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