FDA.report

510(k) K242127

Device
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
Applicant
Instrumentation Laboratory (IL) Co.
510(k) number
K242127
Product code
GKP
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-16
Date received
2024-07-19
Regulation
864.5400
Classification name
Instrument, Coagulation, Automated
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Sneh Pingle
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GKP

510(k)DeviceApplicantDecision date
K231031ACL TOP Family 70 SeriesInstrumentation Laboratory Company2023-06-21
K160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)Instrumentation Laboratory CO2016-03-03
K150877ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LASInstrumentation Laboratory CO2015-12-13
K091980ACL TOP 700 LASInstrumentation Laboratory CO2009-09-22
K073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)Instrumentation Laboratory CO2008-05-04
K063679ACL TOPInstrumentation Laboratory CO2007-01-12
K033414ACL TOP MODEL, TOPInstrumentation Laboratory CO2004-01-12
K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560Dade Behring, Inc.2003-09-08
K023362FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLINFisher Diagnostics2002-12-09
K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000Dade Behring, Inc.2002-06-27
K001645SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500Dade Behring, Inc.2000-08-04
K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CBio/Data Corp.2000-07-12
K001145SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000Dade Behring, Inc.2000-05-11
K993299SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500Dade Behring, Inc.1999-12-07
K993174SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000Dade Behring, Inc.1999-11-09