DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET


Device Classification Name

fibrin split products

510(k) Number K112120
Device Name DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
Applicant
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Applicant Contact abhijit datta
Correspondent
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Correspodent Contact abhijit datta
Regulation Number 864.7320
Classification Product Code
GHH  
Subsequent Product Codes
DAP   JIT  
Date Received 07/25/2011
Decision Date 01/24/2013
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