FDA product code CJG: Tetrabromo-M-Cresolsulfonphthalein, Albumin
CJG is the FDA product code for tetrabromo-m-cresolsulfonphthalein, 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 CJG. The average 510(k) review took 50 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Tetrabromo-M-Cresolsulfonphthalein, 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 CJG clearance
Top CJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bayer Corp. | 1 | 1997-09-09 |
Most recent CJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972706 | Bayer Corp. | CLINITEK MICROALBUMIN REAGENT STRIPS | 1997-09-09 | 50 |
Recalls for CJG devices
openFDA lists no recalls for product code CJG.
Frequently asked questions
What is FDA product code CJG?
CJG is the FDA product code for tetrabromo-m-cresolsulfonphthalein, albumin. It is a Class II device, regulated under 21 CFR 862.1035 and reviewed by the Clinical Chemistry panel.
What device class is CJG?
Class II, regulation 21 CFR 862.1035. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJG?
Across 1 cleared submissions the average was 50 days from receipt to decision (median 50).
Which companies have the most CJG clearances?
Bayer Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJG
- Run a recall and safety report across every CJG manufacturer
- Watch product code CJG 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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