STRATUS CS ACUTE CARE D-DIMER


Device Classification Name

fibrinogen and fibrin split products, antigen, antiserum, control

510(k) Number K110303
Device Name STRATUS CS ACUTE CARE D-DIMER
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
ms 514
newark, 
DE 
19702

Applicant Contact kathleen ann dray-lyons
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
ms 514
newark, 
DE 
19702

Correspodent Contact kathleen ann dray-lyons
Regulation Number 864.7320
Classification Product Code
DAP  
Date Received 02/01/2011
Decision Date 05/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No