HEMOSIL FACTOR XI DEFICIENT PLASMA


Device Classification Name

plasma, coagulation factor deficient

510(k) Number K030287
Device Name HEMOSIL FACTOR XI DEFICIENT PLASMA
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Original Contact carol marble
Regulation Number 864.7290
Classification Product Code
GJT  
Date Received 01/28/2003
Decision Date 03/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No