ClearanceBrief
510(k) K091980 ยท GKP Instrument, Coagulation, Automated

ACL TOP 700 LAS

ApplicantInstrumentation Laboratory CO, Bedford MA, US
DecisionSubstantially Equivalent, Sep 22, 2009
ReceivedJul 1, 2009
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K091980

DateFirm and productCodeLinked 510(k)
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP (Base), automated coagulation laboratory instrument.
Terminated		 GKPNone listed
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 700, automated coagulation laboratory instrument.
Terminated		 GKPNone listed
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP CTS, automated coagulation laboratory instrument.
Terminated		 GKPNone listed
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Terminated		 GKPNone listed
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Terminated		 GKPNone listed
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Terminated		 GKPNone listed
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 300 CTS, automated coagulation laboratory instrument.
Terminated		 GKPNone listed
Sep 18, 2013Instrumentation Laboratory Co.
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrino
Terminated		 GKPNone listed
Sep 18, 2013Instrumentation Laboratory Co.
ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolys
Terminated		 GKPNone listed
Sep 18, 2013Instrumentation Laboratory Co.
ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolys
Terminated		 GKPNone listed
Sep 18, 2013Instrumentation Laboratory Co.
ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrin
Terminated		 GKPNone listed
Sep 18, 2013Instrumentation Laboratory Co.
ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrin
Terminated		 GKPNone listed
Sep 18, 2013Instrumentation Laboratory Co.
ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for c
Terminated		 GKPNone listed
Sep 18, 2013Instrumentation Laboratory Co.
ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrin
Terminated		 GKPNone listed
Sep 14, 2012Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis la
Terminated		 GKPNone listed
Sep 14, 2012Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis labor
Terminated		 GKPNone listed
Sep 14, 2012Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis labo
Terminated		 GKPNone listed
Sep 14, 2012Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis
Terminated		 GKPNone listed
Sep 14, 2012Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis
Terminated		 GKPNone listed
Sep 14, 2012Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis
Terminated		 GKPNone listed
Oct 25, 2010Instrumentation Laboratory Co.
ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolys
Terminated		 GKPNone listed
Oct 25, 2010Instrumentation Laboratory Co.
ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinol
Terminated		 GKPNone listed
Oct 25, 2010Instrumentation Laboratory Co.
ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinol
Terminated		 GKPNone listed
Oct 25, 2010Instrumentation Laboratory Co.
ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis
Terminated		 GKPNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.