DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE— 510(k) K133728

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K133728 for DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2014-01-24. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code CGX
Advisory panel: Clinical Chemistry
Date received: 2013-12-06
Decision date: 2014-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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