Product code JOX— Hematology
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
- Classification name
- Analyzer, Heparin, Automated
- Device class
- Class 2
- Regulation
- 21 CFR 864.5680
- Advisory panel
- Hematology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code JOX
FDA has cleared devices under product code JOX between 1980 and 2011, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2011
- 2010
- 2005
- 2004
- 2000
- 1992
- 1991
- 1989
- 1985
- 1984
- 1983
- 1982
- 1980
Top applicants under product code JOX
Recent clearances under product code JOX
- K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
- K102953 — HEPARIN DOSE RESPONSE CARTRIDGE
- K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
- K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
- K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
- K042070 — HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
- K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
- K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
- K911240 — HEPCON HMS WITH BODY SURFACE AREA CALCULATION
- K894317 — HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
- K854377 — HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
- K841021 — HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
- K830665 — HEPCOL SYSTEM B-10 & B-10-P
- K813011 — HEPAQUANT
- K800161 — HEPCON/SYSTEM RC-10
Data sourced from openFDA. This site is unofficial and independent of the FDA.