FDA product code JBN: Fibrin Monomer Paracoagulation
JBN is the FDA product code for fibrin monomer paracoagulation. It is a Class II device, regulated under 21 CFR 864.7300 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under JBN, from 2 different applicants. The average 510(k) review took 86 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Fibrin Monomer Paracoagulation |
| Device class | Class II |
| Regulation | 21 CFR 864.7300 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JBN clearance
Top JBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Bioproducts Co. | 1 | 1986-03-06 |
| General Diagnostics | 1 | 1978-11-08 |
Most recent JBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854015 | American Bioproducts Co. | FS TEST KIT | 1986-03-06 | 160 |
| K781814 | General Diagnostics | SULFATE, FIBRIQUIK PROTAMINE | 1978-11-08 | 13 |
Recalls for JBN devices
openFDA lists no recalls for product code JBN.
Frequently asked questions
What is FDA product code JBN?
JBN is the FDA product code for fibrin monomer paracoagulation. It is a Class II device, regulated under 21 CFR 864.7300 and reviewed by the Hematology panel.
What device class is JBN?
Class II, regulation 21 CFR 864.7300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JBN?
Across 2 cleared submissions the average was 86 days from receipt to decision (median 86).
Which companies have the most JBN clearances?
American Bioproducts Co. (1); General Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JBN
- Run a recall and safety report across every JBN manufacturer
- Watch product code JBN 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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