JOX — Analyzer, Heparin, Automated Class II
FDA Device Classification
Classification Details
- Product Code
- JOX
- Device Class
- Class II
- Regulation Number
- 864.5680
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K111339 | medtronic | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | June 8, 2011 |
| K102953 | medtronic | HEPARIN DOSE RESPONSE CARTRIDGE | November 4, 2010 |
| K101271 | medtronic | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | October 13, 2010 |
| K051040 | medtronic perfusion systems | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | May 24, 2005 |
| K043080 | medtronic vascular | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | December 3, 2004 |
| K042070 | medtronic vascular | HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 | October 1, 2004 |
| K993519 | cardiovascular diagnostics | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOIN | January 14, 2000 |
| K922031 | medtronic hemotec | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | July 21, 1992 |
| K911240 | hemotech | HEPCON HMS WITH BODY SURFACE AREA CALCULATION | July 17, 1991 |
| K894317 | hemotec | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | September 5, 1989 |
| K854377 | hemotec | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | December 4, 1985 |
| K841021 | hemotec | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | May 25, 1984 |
| K830665 | hemotec | HEPCOL SYSTEM B-10 & B-10-P | June 8, 1983 |
| K813011 | streck laboratories | HEPAQUANT | January 26, 1982 |
| K800161 | hemotec | HEPCON/SYSTEM RC-10 | March 19, 1980 |