STRATUS CS ACUTE CARE D-DIMER— 510(k) K110303

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K110303 for STRATUS CS ACUTE CARE D-DIMER, Substantially Equivalent on 2011-05-16. Applicant: Siemens Healthcare Diagnostics.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code DAP
Advisory panel: Hematology
Date received: 2011-02-01
Decision date: 2011-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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