FDA product code CJR: Acid Phosphatase, Thymol Blue Monophosphate
CJR is the FDA product code for acid phosphatase, thymol blue monophosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under CJR, from 2 different applicants. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Acid Phosphatase, Thymol Blue Monophosphate |
| Device class | Class II |
| Regulation | 21 CFR 862.1020 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CJR clearance
Top CJR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sandare Chemical Co., Inc. | 1 | 1984-08-17 |
| Princeton Biomedix | 1 | 1976-07-20 |
Most recent CJR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842516 | Sandare Chemical Co., Inc. | SANDARE ACID PHOSPHATASE PROCEDURE | 1984-08-17 | 38 |
| K760161 | Princeton Biomedix | TEST, ACID PHOSPHATASE | 1976-07-20 | 18 |
Recalls for CJR devices
openFDA lists no recalls for product code CJR.
Frequently asked questions
What is FDA product code CJR?
CJR is the FDA product code for acid phosphatase, thymol blue monophosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel.
What device class is CJR?
Class II, regulation 21 CFR 862.1020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CJR?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most CJR clearances?
Sandare Chemical Co., Inc. (1); Princeton Biomedix (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJR
- Run a recall and safety report across every CJR manufacturer
- Watch product code CJR 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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