FDA product code CJD: Nitrosalicylate Reduction, Amylase
CJD is the FDA product code for nitrosalicylate reduction, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CJD. The average 510(k) review took 1675 days (median 1675).
Classification
| Field | Value |
|---|---|
| Device name | Nitrosalicylate Reduction, Amylase |
| Device class | Class II |
| Regulation | 21 CFR 862.1070 |
| 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 CJD clearance
Top CJD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tech Intl. Co. | 1 | 1996-06-28 |
Most recent CJD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K915704 | Tech Intl. Co. | AMYLASE (KINETIC) REAGENT SET | 1996-06-28 | 1675 |
Recalls for CJD devices
openFDA lists no recalls for product code CJD.
Frequently asked questions
What is FDA product code CJD?
CJD is the FDA product code for nitrosalicylate reduction, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel.
What device class is CJD?
Class II, regulation 21 CFR 862.1070. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJD?
Across 1 cleared submissions the average was 1675 days from receipt to decision (median 1675).
Which companies have the most CJD clearances?
Tech Intl. Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJD
- Run a recall and safety report across every CJD manufacturer
- Watch product code CJD 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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