FDA product code GJB: Thrombin
GJB is the FDA product code for thrombin. It is a Class II device, regulated under 21 CFR 864.7875 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GJB. The average 510(k) review took 41 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Thrombin |
| Device class | Class II |
| Regulation | 21 CFR 864.7875 |
| 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 GJB clearance
Top GJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Dade | 1 | 1982-02-22 |
Most recent GJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820084 | American Dade | CLOTTING TIME REAGENT | 1982-02-22 | 41 |
Recalls for GJB devices
openFDA lists no recalls for product code GJB.
Frequently asked questions
What is FDA product code GJB?
GJB is the FDA product code for thrombin. It is a Class II device, regulated under 21 CFR 864.7875 and reviewed by the Hematology panel.
What device class is GJB?
Class II, regulation 21 CFR 864.7875. Typical premarket route: 510(k).
How long does a 510(k) take for product code GJB?
Across 1 cleared submissions the average was 41 days from receipt to decision (median 41).
Which companies have the most GJB clearances?
American Dade (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GJB
- Run a recall and safety report across every GJB manufacturer
- Watch product code GJB 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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