Test, Heparin Neutralization
A heparin neutralization test is a laboratory assay used to evaluate the coagulation status of patients by measuring clotting parameters in the presence of heparin-neutralizing agents, allowing assessment of underlying coagulation function independent of heparin anticoagulant effects. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JBR, regulated under 21 CFR 864.7525, within the Hematology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JBR
- Device Class
- FDA class 2
- Regulation Number
- 864.7525
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K925452 | DADE HEPZYME | Jan 11, 1993 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K874373 | PT PRO-CLOT | Jan 05, 1988 | Substantially Equivalent | Probe-Tek, Inc. |
| K770722 | THROMBO SCREEN QUANTITATIVE HEPARIN ASSA | Jul 11, 1977 | Substantially Equivalent | Bay Area Hema. Onco. Clinic. & Res. L |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.