JOX — Analyzer, Heparin, Automated Class II
FDA product code JOX covers "Analyzer, Heparin, Automated", a Class II medical device regulated under 21 CFR 864.5680. Submissions are reviewed by the Hematology panel. At least 15 recent 510(k) clearances have been granted under this product code.
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 |