PATHFAST D-DIMER


Device Classification Name

fibrin split products

510(k) Number K072288
Device Name PATHFAST D-DIMER
Applicant
MITSUBISHI KAGAKU IATRON
701 fifth avenue
floor 42
seattle, 
WA 
98104

Applicant Contact helen landicho
Correspondent
MITSUBISHI KAGAKU IATRON
701 fifth avenue
floor 42
seattle, 
WA 
98104

Correspodent Contact helen landicho
Regulation Number 864.7320
Classification Product Code
GHH  
Date Received 08/16/2007
Decision Date 05/06/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No