FDA 510(k) Applications for Medical Device Product Code "GKP"
(Instrument, Coagulation, Automated)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961579 | AMERICAN BIOPRODUCTS CO. | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | 07/10/1996 |
| K001891 | BIO/DATA CORP. | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | 07/12/2000 |
| K981206 | CARDIOVASCULAR DIAGNOSTICS, INC. | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) | 05/26/1998 |
| K031377 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 | 09/08/2003 |
| K020979 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 | 06/27/2002 |
| K993299 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | 12/07/1999 |
| K001645 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | 08/04/2000 |
| K992423 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | 09/21/1999 |
| K992763 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | 09/21/1999 |
| K992321 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | 09/17/1999 |
| K993174 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | 11/09/1999 |
| K001145 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | 05/11/2000 |
| K964139 | DADE INTL., INC. | SYSMEX CA-6000 | 02/06/1997 |
| K023362 | FISHER DIAGNOSTICS | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | 12/09/2002 |
| K954437 | HAEMOSCOPE CORP. | THROMBELASTOGRAPH COAGULATION ANALYZER 3000S | 01/30/1996 |
| K242127 | Instrumentation Laboratory (IL) Co. | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | 08/16/2024 |
| K961991 | INSTRUMENTATION LABORATORY CO. | ACL 6000 SYSTEM (ACL 6000) | 09/04/1996 |
| K063679 | INSTRUMENTATION LABORATORY CO. | ACL TOP | 01/12/2007 |
| K160276 | INSTRUMENTATION LABORATORY CO. | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | 03/03/2016 |
| K073377 | INSTRUMENTATION LABORATORY CO. | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) | 05/04/2008 |
| K091980 | INSTRUMENTATION LABORATORY CO. | ACL TOP 700 LAS | 09/22/2009 |
| K150877 | Instrumentation Laboratory Co. | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS | 12/13/2015 |
| K033414 | INSTRUMENTATION LABORATORY CO. | ACL TOP MODEL, TOP | 01/12/2004 |
| K231031 | Instrumentation Laboratory Company | ACL TOP Family 70 Series | 06/21/2023 |
| K962664 | MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. | ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER | 09/10/1996 |
| K991101 | ORGANON TEKNIKA CORP. | COAG-A-MATE MAX | 06/01/1999 |
| K962857 | ORGANON TEKNIKA CORP. | COAG-A-MATE MTX | 01/22/1997 |
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