HEMOSIL SILICA CLOTTING TIME


Device Classification Name

activated partial thromboplastin

510(k) Number K050221
Device Name HEMOSIL SILICA CLOTTING TIME
Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Applicant Contact carol marble
Correspondent
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Correspodent Contact carol marble
Regulation Number 864.7925
Classification Product Code
GFO  
Date Received 01/31/2005
Decision Date 03/30/2005
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