Product code GKP
- Device name
- Instrument, Coagulation, Automated
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5400
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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. | 2024-08-16 |
| K231031 | ACL TOP Family 70 Series | Instrumentation Laboratory Company | 2023-06-21 |
| 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 | 2016-03-03 |
| 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 | 2015-12-13 |
| K091980 | ACL TOP 700 LAS | Instrumentation Laboratory CO | 2009-09-22 |
| K073377 | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) | Instrumentation Laboratory CO | 2008-05-04 |
| K063679 | ACL TOP | Instrumentation Laboratory CO | 2007-01-12 |
| K033414 | ACL TOP MODEL, TOP | Instrumentation Laboratory CO | 2004-01-12 |
| K031377 | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 | Dade Behring, Inc. | 2003-09-08 |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | Fisher Diagnostics | 2002-12-09 |
| K020979 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 | Dade Behring, Inc. | 2002-06-27 |
| K001645 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | 2000-08-04 |
| K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | Bio/Data Corp. | 2000-07-12 |
| K001145 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | 2000-05-11 |
| K993299 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | 1999-12-07 |
| K993174 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | 1999-11-09 |
| K992423 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | Dade Behring, Inc. | 1999-09-21 |
| K992763 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | Dade Behring, Inc. | 1999-09-21 |
| K992321 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | 1999-09-17 |
| K991101 | COAG-A-MATE MAX | Organon Teknika Corp. | 1999-06-01 |
| K981206 | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) | Cardiovascular Diagnostics, Inc. | 1998-05-26 |
| K964139 | SYSMEX CA-6000 | Dade Intl., Inc. | 1997-02-06 |
| K962857 | COAG-A-MATE MTX | Organon Teknika Corp. | 1997-01-22 |
| K962664 | ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER | Medical Laboratory Automation Systems, Inc. | 1996-09-10 |
| K961991 | ACL 6000 SYSTEM (ACL 6000) | Instrumentation Laboratory CO | 1996-09-04 |
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | American Bioproducts Co. | 1996-07-10 |
| K954437 | THROMBELASTOGRAPH COAGULATION ANALYZER 3000S | Haemoscope Corp. | 1996-01-30 |
| K951072 | PROTIME MICROCOAGULATION SYSTEM | International Technidyne Corp. | 1995-10-27 |
| K943153 | MICROSAMPLE COAGULATION ANALYZER | Bio/Data Corp. | 1995-03-24 |
| K944227 | ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER | Medical Laboratory Automation Systems, Inc. | 1995-02-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195226000528 | ACL TOP 770 | INSTRUMENTATION LABORATORY COMPANY | 2024-05-15 |
| 00195226000535 | ACL TOP 770 LAS | INSTRUMENTATION LABORATORY COMPANY | 2024-05-15 |
| 00195226000542 | ACL TOP 770s | INSTRUMENTATION LABORATORY COMPANY | 2024-05-15 |
| 00195226000559 | ACL TOP 570 | INSTRUMENTATION LABORATORY COMPANY | 2024-05-15 |
| 00195226000566 | ACL TOP 370 | INSTRUMENTATION LABORATORY COMPANY | 2024-05-15 |
| 04987562516797 | CA CAL S | SYSMEX CORPORATION | 2024-02-22 |
| 04987562518678 | Automated Blood Coagulation Analyzer CA-600 series CA-620 | SYSMEX CORPORATION | 2024-02-22 |
| 04987562518685 | Automated Blood Coagulation Analyzer CA-600 series CA-660 | SYSMEX CORPORATION | 2024-02-22 |
| 10850044118042 | iHealth | IHEALTH LAB INC. | 2022-09-30 |
| 10850044118059 | iHealth | IHEALTH LAB INC. | 2022-09-30 |
| 08426950784050 | ACL TOP 750 LAS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950451600 | ACL TOP CTS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950453499 | ACL TOP 500 CTS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950497974 | ACL TOP 700 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950497981 | ACL TOP 700 CTS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950497998 | ACL TOP 700 LAS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950556916 | ACL TOP 300 CTS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950729242 | ACL TOP 550 CTS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950062295 | HemosIL Factor Diluent | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950784067 | ACL TOP 750 CTS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950927990 | ACL TOP 700 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950784081 | ACL TOP 350 CTS | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950784074 | ACL TOP 750 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950497059 | ACL AcuStar cuvettes (1400 pcs) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950075899 | Cuvettes (2400 cuvettes) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950055990 | HemosIL Cleaning Solution (Clean A) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950003106 | HemosIL Sample Diluent | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 03607450582307 | ST art® | DIAGNOSTICA STAGO | 2016-09-15 |
| M52517110000 | Cascade M-4 (110V/220V) | HELENA LABORATORIES CORPORATION | 2016-08-22 |
| 04987562425686 | Automated Blood Coagulation Analyzer CA-600 series CA-620 | SYSMEX CORPORATION | 2016-08-04 |