Home / 510(k) Clearances / K150877

510(k) K150877

ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS by Instrumentation Laboratory CO — Product Code GKP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 13, 2015
Date Received: April 1, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Instrument, Coagulation, Automated
Device Class: Class II
Regulation Number: 864.5400
Review Panel: HE
Submission Type

Other clearances by Instrumentation Laboratory CO

K233790 — ACL TOP 970 CL (December 29, 2023)
K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein (September 29, 2023)
K223608 — GEM Premier 7000 with IQM3 (August 10, 2023)
K223187 — HemosIL Liquid Anti-Xa (June 23, 2023)
K231031 — ACL TOP Family 70 Series (June 21, 2023)
K223090 — GEM Premier ChemSTAT (January 27, 2023)
K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
K213426 — HemosIL ReadiPlasTin (August 16, 2022)

Other clearances for product code GKP

K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP (August 16, 2024)
K231031 — ACL TOP Family 70 Series (June 21, 2023)
K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP (March 3, 2016)
K091980 — ACL TOP 700 LAS (September 22, 2009)
K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (May 4, 2008)
K063679 — ACL TOP (January 12, 2007)
K033414 — ACL TOP MODEL, TOP (January 12, 2004)
K031377 — SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -5 (September 8, 2003)
K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)
K020979 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 (June 27, 2002)