HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM


Device Classification Name

reagent, russel viper venom

510(k) Number K110031
Device Name HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Applicant Contact jacqueline emery
Correspondent
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Correspodent Contact jacqueline emery
Regulation Number 864.8950
Classification Product Code
GIR  
Subsequent Product Code
GGC  
Date Received 01/05/2011
Decision Date 08/24/2011
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