DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE— 510(k) K132638

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K132638 for DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2014-01-27. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code CGX
Advisory panel: Clinical Chemistry
Date received: 2013-08-23
Decision date: 2014-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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