JBR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Heparin Neutralization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7525
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DADE HEPZYME (K925452) | Baxter Diagnostics, Inc. | 1993-01-11 |
| PT PRO-CLOT (K874373) | Probe-Tek, Inc. | 1988-01-05 |
| THROMBO SCREEN QUANTITATIVE HEPARIN ASSA (K770722) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-07-11 |
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Every clearance here is in the API, with alerts when new ones post.