HEMOSIL FIBRINOGEN-C


Device Classification Name

system, fibrinogen determination

510(k) Number K073367
Device Name HEMOSIL FIBRINOGEN-C
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 864.7340
Classification Product Code
KQJ  
Date Received 11/30/2007
Decision Date 12/27/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No