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)
Top companies in GKP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 2024 | K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) Instrumentation Laboratory (IL) Co. | GKP |
| Jun 21, 2023 | K231031 | ACL TOP Family 70 Series Instrumentation Laboratory Company | GKP |
| Mar 3, 2016 | K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) Instrumentation Laboratory CO | GKP |
| Dec 13, 2015 | 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 Instrumentation Laboratory CO | GKP |
| Sep 22, 2009 | K091980 | ACL TOP 700 LAS Instrumentation Laboratory CO | GKP |
| May 4, 2008 | K073377 | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) Instrumentation Laboratory CO | GKP |
| Jan 12, 2007 | K063679 | ACL TOP Instrumentation Laboratory CO | GKP |
| Jan 12, 2004 | K033414 | ACL TOP MODEL, TOP Instrumentation Laboratory CO | GKP |
| Sep 8, 2003 | K031377 | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 Dade Behring, Inc. | GKP |
| Dec 9, 2002 | K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN Fisher Diagnostics | GKP |
| Jun 27, 2002 | K020979 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 Dade Behring, Inc. | GKP |
| Aug 4, 2000 | K001645 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 Dade Behring, Inc. | GKP |
| Jul 12, 2000 | K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C Bio/Data Corp. | GKP |
| May 11, 2000 | K001145 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 Dade Behring, Inc. | GKP |
| Dec 7, 1999 | K993299 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 Dade Behring, Inc. | GKP |
| Nov 9, 1999 | K993174 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 Dade Behring, Inc. | GKP |
| Sep 21, 1999 | K992763 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 Dade Behring, Inc. | GKP |
| Sep 21, 1999 | K992423 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 Dade Behring, Inc. | GKP |
| Sep 17, 1999 | K992321 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 Dade Behring, Inc. | GKP |
| Jun 1, 1999 | K991101 | COAG-A-MATE MAX Organon Teknika Corp. | GKP |
| May 26, 1998 | K981206 | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) Cardiovascular Diagnostics, Inc. | GKP |
| Feb 6, 1997 | K964139 | SYSMEX CA-6000 Dade Intl., Inc. | GKP |
| Jan 22, 1997 | K962857 | COAG-A-MATE MTX Organon Teknika Corp. | GKP |
| Sep 10, 1996 | K962664 | ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER Medical Laboratory Automation Systems, Inc. | GKP |
| Sep 4, 1996 | K961991 | ACL 6000 SYSTEM (ACL 6000) Instrumentation Laboratory CO | GKP |
| Jul 10, 1996 | K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co. | GKP |
| Jan 30, 1996 | K954437 | THROMBELASTOGRAPH COAGULATION ANALYZER 3000S Haemoscope Corp. | GKP |
| Oct 27, 1995 | K951072 | PROTIME MICROCOAGULATION SYSTEM International Technidyne Corp. | GKP |
| Mar 24, 1995 | K943153 | MICROSAMPLE COAGULATION ANALYZER Bio/Data Corp. | GKP |
| Feb 3, 1995 | K944227 | ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER Medical Laboratory Automation Systems, Inc. | GKP |
| Feb 1, 1995 | K942117 | STA AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co. | GKP |
| Dec 22, 1994 | K931992 | HEMOLAB Biomerieux Vitek, Inc. | GKP |
| Nov 15, 1993 | K933092 | TAS ANALYZER Cardiovascular Diagnostic Services | GKP |
| Aug 23, 1993 | K931956 | CASCADE M, CAT. NO. 1710 Helena Laboratories | GKP |
| Aug 23, 1993 | K931206 | ELECTRA 1600C AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. | GKP |
| Jun 18, 1993 | K924098 | IL MCL-2 COAGULATION ANALYZER Instrumentation Laboratory CO | GKP |
| Jun 29, 1992 | K921465 | CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) Helena Laboratories | GKP |
| Jun 9, 1992 | K921363 | CASCADE 480 Helena Laboratories | GKP |
| Jan 13, 1992 | K914946 | CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION Helena Laboratories | GKP |
| Nov 13, 1990 | K904297 | ST-4 COAGULATION INSTRUMENT American Bioproducts Co. | GKP |
| Nov 1, 1990 | K904204 | THROMBELASTOGRAPH Haemoscope Corp. | GKP |
| May 25, 1990 | K901380 | CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430 Helena Laboratories | GKP |
| May 22, 1990 | K901120 | KOAGULAB 60-S COAGULATION SYSTEM Ortho Diagnostic Systems, Inc. | GKP |
| Oct 24, 1989 | K895844 | THROMBELASTOGRAPH(R) Haemoscope Corp. | GKP |
| Jul 27, 1989 | K894052 | ELECTRA 1000C AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. | GKP |
| Feb 3, 1989 | K885035 | KOAGULAB* 32-S COAGULATION SYSTEM Ortho Diagnostic Systems, Inc. | GKP |
| Feb 3, 1989 | K884863 | ELECTRA 900C AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. | GKP |
| May 18, 1988 | K881281 | COAG-A-MATE(R) XM Organon Teknika Corp. | GKP |
| Jan 28, 1982 | K813564 | COAG-A-MATE X2 General Diagnostics | GKP |
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