FDA product code CJT: Hydrazone Colorimetry, Aldolase
CJT is the FDA product code for hydrazone colorimetry, aldolase. It is a Class I device, regulated under 21 CFR 862.1040 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CJT. The average 510(k) review took 8 days (median 8).
Classification
| Field | Value |
|---|---|
| Device name | Hydrazone Colorimetry, Aldolase |
| Device class | Class I |
| Regulation | 21 CFR 862.1040 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CJT clearance
Top CJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1976-10-21 |
Most recent CJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K760821 | Sigma Chemical Co. | REAGENT SYSTEM | 1976-10-21 | 8 |
Recalls for CJT devices
openFDA lists no recalls for product code CJT.
Frequently asked questions
What is FDA product code CJT?
CJT is the FDA product code for hydrazone colorimetry, aldolase. It is a Class I device, regulated under 21 CFR 862.1040 and reviewed by the Clinical Chemistry panel.
What device class is CJT?
Class I, regulation 21 CFR 862.1040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CJT?
Across 1 cleared submissions the average was 8 days from receipt to decision (median 8).
Which companies have the most CJT clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJT
- Run a recall and safety report across every CJT manufacturer
- Watch product code CJT 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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