ClearanceBrief
Panels › Hematology › Product code GKP · Class 2

Instrument, Coagulation, Automated

Regulation 864.5400

0510(k)s in 12 months (49 all time)
0recalls in 12 months (31 all time)
30recalls that name a 510(k)
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Top companies in GKP

Company510(k)sRecalls
Instrumentation Laboratory CO927
Dade Behring, Inc.90
Helena Laboratories50
Medical Laboratory Automation Systems, Inc.50
American Bioproducts Co.30
Diagnostica Stago, Inc.03
Haemoscope Corp.30
Organon Teknika Corp.30
Bio/Data Corp.20
Ortho Diagnostic Systems, Inc.20
DateFirm and productCodeLinked 510(k)
Sep 12, 2023Instrumentation Laboratory
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis
Open, Classified		 GKPK150877
Apr 28, 2022Instrumentation Laboratory
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000
Open, Classified		 GKPK160276
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 300 CTS, automated coagulation laboratory instrument.
Terminated		 GKPK091980
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Terminated		 GKPK091980
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Terminated		 GKPK091980
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Terminated		 GKPK091980
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP CTS, automated coagulation laboratory instrument.
Terminated		 GKPK091980
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP 700, automated coagulation laboratory instrument.
Terminated		 GKPK091980
Jul 16, 2014Instrumentation Laboratory Co.
ACL TOP (Base), automated coagulation laboratory instrument.
Terminated		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
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		 GKPK091980
Oct 11, 2007Diagnostica Stago, Inc.
STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Terminated		 GKPK961579
Aug 7, 2007Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000
Terminated		 GKPK063679
May 16, 2007Diagnostica Stago, Inc.
STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France
Terminated		 GKPK961579
Jul 20, 2004Biomerieux, Inc.
Coag-A-Mate MTX and MTX II Instrument Operator Manual
Terminated		 GKPNone listed
May 29, 2003Diagnostica Stago, Inc.
STA-Compact Hemostasis System with Cap piercing capability.
Terminated		 GKPK961579
K983460

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