FDA Product Code
FDA Product Code JOX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5680
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111339 | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | Medtronic, Inc. | 2011-06-08 | Special | PDF ↗ |
| K102953 | HEPARIN DOSE RESPONSE CARTRIDGE | Medtronic, Inc. | 2010-11-04 | Special | PDF ↗ |
| K101271 | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | Medtronic, Inc. | 2010-10-13 | Special | PDF ↗ |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Perfusion Systems | 2005-05-24 | Special | PDF ↗ |
| K043080 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Vascular | 2004-12-03 | Special | PDF ↗ |
| K042070 | HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 | Medtronic Vascular | 2004-10-01 | Special | PDF ↗ |
| K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST | Cardiovascular Diagnostics, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K922031 | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | Medtronic Hemotec, Inc. | 1992-07-21 | Traditional | PDF ↗ |
| K911240 | HEPCON HMS WITH BODY SURFACE AREA CALCULATION | Hemotech, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Hemotec, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Hemotec, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K841021 | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | Hemotec, Inc. | 1984-05-25 | Traditional | PDF ↗ |
| K830665 | HEPCOL SYSTEM B-10 & B-10-P | Hemotec, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K813011 | HEPAQUANT | Streck Laboratories, Inc. | 1982-01-26 | Traditional | PDF ↗ |
| K800161 | HEPCON/SYSTEM RC-10 | Hemotec, Inc. | 1980-03-19 | Traditional | PDF ↗ |
Product code JOX · Class II · Hematology. Data: openFDA.