MODIFICATION OF ACL ADVANCE


information about

Device Classification Name

system, multipurpose for in vitro coagulation studies

510(k) Number K002400
Device Name MODIFICATION OF ACL ADVANCE
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Original Contact carol marble
Regulation Number 864.5425
Classification Product Code
JPA  
Date Received 08/04/2000
Decision Date 08/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls