FDA product code CJF: Tetrabromophenolphthalein, Albumin
CJF is the FDA product code for tetrabromophenolphthalein, albumin. It is a Class II device, regulated under 21 CFR 862.1035 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CJF. The average 510(k) review took 34 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Tetrabromophenolphthalein, Albumin |
| Device class | Class II |
| Regulation | 21 CFR 862.1035 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CJF clearance
Top CJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amresco, Inc. | 1 | 1983-03-24 |
Most recent CJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830535 | Amresco, Inc. | FLOW-PAC ALKALINE PHOSPHATE REAGENT SET | 1983-03-24 | 34 |
Recalls for CJF devices
openFDA lists no recalls for product code CJF.
Frequently asked questions
What is FDA product code CJF?
CJF is the FDA product code for tetrabromophenolphthalein, albumin. It is a Class II device, regulated under 21 CFR 862.1035 and reviewed by the Clinical Chemistry panel.
What device class is CJF?
Class II, regulation 21 CFR 862.1035. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJF?
Across 1 cleared submissions the average was 34 days from receipt to decision (median 34).
Which companies have the most CJF clearances?
Amresco, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJF
- Run a recall and safety report across every CJF manufacturer
- Watch product code CJF 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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