FDA product code JBR: Test, Heparin Neutralization
JBR is the FDA product code for test, heparin neutralization. It is a Class II device, regulated under 21 CFR 864.7525 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under JBR, from 3 different applicants. The average 510(k) review took 76 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Test, Heparin Neutralization |
| Device class | Class II |
| Regulation | 21 CFR 864.7525 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JBR clearance
Top JBR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Diagnostics, Inc. | 1 | 1993-01-11 |
| Probe-Tek, Inc. | 1 | 1988-01-05 |
| Bay Area Hema. Onco. Clinic. & Res. L | 1 | 1977-07-11 |
Most recent JBR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925452 | Baxter Diagnostics, Inc. | DADE HEPZYME | 1993-01-11 | 75 |
| K874373 | Probe-Tek, Inc. | PT PRO-CLOT | 1988-01-05 | 71 |
| K770722 | Bay Area Hema. Onco. Clinic. & Res. L | THROMBO SCREEN QUANTITATIVE HEPARIN ASSA | 1977-07-11 | 83 |
Recalls for JBR devices
openFDA lists no recalls for product code JBR.
Frequently asked questions
What is FDA product code JBR?
JBR is the FDA product code for test, heparin neutralization. It is a Class II device, regulated under 21 CFR 864.7525 and reviewed by the Hematology panel.
What device class is JBR?
Class II, regulation 21 CFR 864.7525. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBR?
Across 3 cleared submissions the average was 76 days from receipt to decision (median 75).
Which companies have the most JBR clearances?
Baxter Diagnostics, Inc. (1); Probe-Tek, Inc. (1); Bay Area Hema. Onco. Clinic. & Res. L (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JBR
- Run a recall and safety report across every JBR manufacturer
- Watch product code JBR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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