FDA product code CJH: Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes
CJH is the FDA product code for thymol blue monophosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CJH. The average 510(k) review took 50 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1050 |
| 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 CJH clearance
Top CJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electrophoresis Corp. of America | 1 | 1980-01-29 |
Most recent CJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792551 | Electrophoresis Corp. of America | ALKALINE PHOSPHATASE REAGENT | 1980-01-29 | 50 |
Recalls for CJH devices
openFDA lists no recalls for product code CJH.
Frequently asked questions
What is FDA product code CJH?
CJH is the FDA product code for thymol blue monophosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel.
What device class is CJH?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJH?
Across 1 cleared submissions the average was 50 days from receipt to decision (median 50).
Which companies have the most CJH clearances?
Electrophoresis Corp. of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJH
- Run a recall and safety report across every CJH manufacturer
- Watch product code CJH 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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