FDA product code JBZ: Study, Platelet Adhesive
JBZ is the FDA product code for study, platelet adhesive. It is a Class II device, regulated under 21 CFR 864.6650 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under JBZ, from 3 different applicants. The average 510(k) review took 72 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Study, Platelet Adhesive |
| Device class | Class II |
| Regulation | 21 CFR 864.6650 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JBZ clearance
Top JBZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hemometrix | 1 | 1980-02-05 |
| Bay Area Hema. Onco. Clinic. & Res. L | 1 | 1977-11-22 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1977-11-22 |
Most recent JBZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K800037 | Hemometrix | PLATELET RETENTION (ADHESION) COLUMNS | 1980-02-05 | 29 |
| K771678 | Bay Area Hema. Onco. Clinic. & Res. L | THROMBO-SCREEN PLATELET ADHESION | 1977-11-22 | 81 |
| K771523 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LATELET RETENTION COLUMN | 1977-11-22 | 106 |
Recalls for JBZ devices
openFDA lists no recalls for product code JBZ.
Frequently asked questions
What is FDA product code JBZ?
JBZ is the FDA product code for study, platelet adhesive. It is a Class II device, regulated under 21 CFR 864.6650 and reviewed by the Hematology panel.
What device class is JBZ?
Class II, regulation 21 CFR 864.6650. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JBZ?
Across 3 cleared submissions the average was 72 days from receipt to decision (median 81).
Which companies have the most JBZ clearances?
Hemometrix (1); Bay Area Hema. Onco. Clinic. & Res. L (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JBZ
- Run a recall and safety report across every JBZ manufacturer
- Watch product code JBZ 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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