Analyzer, Heparin, Automated
The Analyzer, Heparin, Automated is a hematology laboratory instrument used to automatically measure heparin concentration in patient blood samples to monitor anticoagulation therapy, supporting safe dosing of heparin during surgical procedures, dialysis, and treatment of thromboembolic disease. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOX and is regulated under 21 CFR 864.5680, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JOX
- Device Class
- FDA class 2
- Regulation Number
- 864.5680
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111339 | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | Jun 08, 2011 | Substantially Equivalent | Medtronic, Inc. |
| K102953 | HEPARIN DOSE RESPONSE CARTRIDGE | Nov 04, 2010 | Substantially Equivalent | Medtronic, Inc. |
| K101271 | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | Oct 13, 2010 | Substantially Equivalent | Medtronic, Inc. |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | May 24, 2005 | Substantially Equivalent | Medtronic Perfusion Systems |
| K043080 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Dec 03, 2004 | Substantially Equivalent | Medtronic Vascular |
| K042070 | HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 | Oct 01, 2004 | Substantially Equivalent | Medtronic Vascular |
| K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST | Jan 14, 2000 | Substantially Equivalent | Cardiovascular Diagnostics, Inc. |
| K922031 | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | Jul 21, 1992 | Substantially Equivalent | Medtronic Hemotec, Inc. |
| K911240 | HEPCON HMS WITH BODY SURFACE AREA CALCULATION | Jul 17, 1991 | Substantially Equivalent | Hemotech, Inc. |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Sep 05, 1989 | Substantially Equivalent | Hemotec, Inc. |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Dec 04, 1985 | Substantially Equivalent | Hemotec, Inc. |
| K841021 | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | May 25, 1984 | Substantially Equivalent | Hemotec, Inc. |
| K830665 | HEPCOL SYSTEM B-10 & B-10-P | Jun 08, 1983 | Substantially Equivalent | Hemotec, Inc. |
| K813011 | HEPAQUANT | Jan 26, 1982 | Substantially Equivalent | Streck Laboratories, Inc. |
| K800161 | HEPCON/SYSTEM RC-10 | Mar 19, 1980 | Substantially Equivalent | Hemotec, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.