510(k) K993519
- Device
- RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
- Applicant
- CARDIOVASCULAR DIAGNOSTICS, INC.
- 510(k) number
- K993519
- Product code
- JOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-14
- Date received
- 1999-10-18
- Regulation
- 864.5680
- Classification name
- Analyzer, Heparin, Automated
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER SCOTT
- Address
- 5301 Departure Dr. Raleigh NC US 27616 27616
FDA Registration Numbers#
- 2184009
- 3010009632
- 1718389
Source Documents#
Other 510(k) Records For Product Code JOX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111339 | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | Medtronic, Inc. | 2011-06-08 |
| K102953 | HEPARIN DOSE RESPONSE CARTRIDGE | Medtronic, Inc. | 2010-11-04 |
| K101271 | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | Medtronic, Inc. | 2010-10-13 |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Perfusion Systems | 2005-05-24 |
| K043080 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Vascular | 2004-12-03 |
| K042070 | HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 | Medtronic Vascular | 2004-10-01 |
| K922031 | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | Medtronic Hemotec, Inc. | 1992-07-21 |
| K911240 | HEPCON HMS WITH BODY SURFACE AREA CALCULATION | Hemotech, Inc. | 1991-07-17 |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Hemotec, Inc. | 1989-09-05 |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Hemotec, Inc. | 1985-12-04 |
| K841021 | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | Hemotec, Inc. | 1984-05-25 |
| K830665 | HEPCOL SYSTEM B-10 & B-10-P | Hemotec, Inc. | 1983-06-08 |
| K813011 | HEPAQUANT | Streck Laboratories, Inc. | 1982-01-26 |
| K800161 | HEPCON/SYSTEM RC-10 | Hemotec, Inc. | 1980-03-19 |
Legacy Summary#
summary
FDA Review#
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