FDA 510(k) K150877, ACL TOP Family 50 Series (350 CTS, 550 CTS, 750, 750 CTS, 750 LAS), by Instrumentation Laboratory CO

510(K) Number: K150877
Device Name: ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
Manufacturer: Instrumentation Laboratory CO
Device Classification Name: instrument, coagulation, automated
Regulation Number: 864.5400
Classification Product Code: GKP
Date Received: 04/01/2015
Decision Date: 12/13/2015
Regulation Medical Specialty: Hematology

Total pages: 7365
Fully redacted pages: 3584
Content pages: 3781