GKP — Instrument, Coagulation, Automated Class II
FDA product code GKP covers "Instrument, Coagulation, Automated", a Class II medical device regulated under 21 CFR 864.5400. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKP
- Device Class
- Class II
- Regulation Number
- 864.5400
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242127 | instrumentation laboratory (il) | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP | August 16, 2024 |
| K231031 | instrumentation laboratory | ACL TOP Family 70 Series | June 21, 2023 |
| K160276 | instrumentation laboratory | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP | March 3, 2016 |
| K150877 | instrumentation laboratory | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP | December 13, 2015 |
| K091980 | instrumentation laboratory | ACL TOP 700 LAS | September 22, 2009 |
| K073377 | instrumentation laboratory | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) | May 4, 2008 |
| K063679 | instrumentation laboratory | ACL TOP | January 12, 2007 |
| K033414 | instrumentation laboratory | ACL TOP MODEL, TOP | January 12, 2004 |
| K031377 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -5 | September 8, 2003 |
| K023362 | fisher diagnostics | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU | December 9, 2002 |
| K020979 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 | June 27, 2002 |
| K001645 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | August 4, 2000 |
| K001891 | bio/data | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | July 12, 2000 |
| K001145 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | May 11, 2000 |
| K993299 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | December 7, 1999 |
| K993174 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | November 9, 1999 |
| K992763 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | September 21, 1999 |
| K992423 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | September 21, 1999 |
| K992321 | dade behring | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | September 17, 1999 |
| K991101 | organon teknika | COAG-A-MATE MAX | June 1, 1999 |