ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)


Device Classification Name

instrument, coagulation, automated

510(k) Number K073377
Device Name ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
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 864.5400
Classification Product Code
GKP  
Date Received 12/03/2007
Decision Date 05/04/2008
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

Recalls CDRH Recalls