GKP · Instrument, Coagulation, Automated
Hematology · 21 CFR 864.5400 · Class 2
Overview
| Product Code | GKP |
|---|---|
| Device Name | Instrument, Coagulation, Automated |
| Regulation | 21 CFR 864.5400 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
Classification Rationale
Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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. | Aug 16, 2024 | SESE |
| K231031 | ACL TOP Family 70 Series | Instrumentation Laboratory Company | Jun 21, 2023 | SESE |
| 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 | Mar 3, 2016 | SESE |
| 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 | Dec 13, 2015 | SESE |
| K091980 | ACL TOP 700 LAS | Instrumentation Laboratory CO | Sep 22, 2009 | SESE |
| K073377 | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) | Instrumentation Laboratory CO | May 4, 2008 | SESE |
| K063679 | ACL TOP | Instrumentation Laboratory CO | Jan 12, 2007 | SESE |
| K033414 | ACL TOP MODEL, TOP | Instrumentation Laboratory CO | Jan 12, 2004 | SESE |
| K031377 | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 | Dade Behring, Inc. | Sep 8, 2003 | SESE |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | Fisher Diagnostics | Dec 9, 2002 | SESE |
| K020979 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 | Dade Behring, Inc. | Jun 27, 2002 | SESE |
| K001645 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | Aug 4, 2000 | SESE |
| K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | Bio/Data Corp. | Jul 12, 2000 | SESE |
| K001145 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | May 11, 2000 | SESE |
| K993299 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | Dec 7, 1999 | SESE |
| K993174 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | Nov 9, 1999 | SESE |
| K992763 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | Dade Behring, Inc. | Sep 21, 1999 | SESE |
| K992423 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | Dade Behring, Inc. | Sep 21, 1999 | SESE |
| K992321 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | Sep 17, 1999 | SESE |
| K991101 | COAG-A-MATE MAX | Organon Teknika Corp. | Jun 1, 1999 | SESE |
Top Applicants
- Dade Behring, Inc. — 9 clearances
- Instrumentation Laboratory CO — 8 clearances
- Helena Laboratories — 5 clearances
- Medical Laboratory Automation Systems, Inc. — 5 clearances
- American Bioproducts Co. — 3 clearances
