MODIFICATION TO COATEST FACTOR VIII

Device Classification Name

test, qualitative and quantitative factor deficiency

510(k) Number K033631
Device Name MODIFICATION TO COATEST FACTOR VIII
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 864.7290
Classification Product Code
GGP  
Date Received 11/19/2003
Decision Date 12/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No