FDA product code CHT: Electrophoretic Method, Catecholamines
CHT is the FDA product code for electrophoretic method, catecholamines. It is a Class I device, regulated under 21 CFR 862.1165 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under CHT, from 2 different applicants. The average 510(k) review took 40 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Electrophoretic Method, Catecholamines |
| Device class | Class I |
| Regulation | 21 CFR 862.1165 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CHT clearance
Top CHT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 1 | 1991-09-25 |
| The Upjohn Co. | 1 | 1976-11-09 |
Most recent CHT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913196 | Eastman Kodak Company | KODAK EKTACHEM DT SLIDES (LIPASE) | 1991-09-25 | 69 |
| K760920 | The Upjohn Co. | CAT-A-KIT | 1976-11-09 | 12 |
Recalls for CHT devices
openFDA lists no recalls for product code CHT.
Frequently asked questions
What is FDA product code CHT?
CHT is the FDA product code for electrophoretic method, catecholamines. It is a Class I device, regulated under 21 CFR 862.1165 and reviewed by the Clinical Chemistry panel.
What device class is CHT?
Class I, regulation 21 CFR 862.1165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CHT?
Across 2 cleared submissions the average was 40 days from receipt to decision (median 40).
Which companies have the most CHT clearances?
Eastman Kodak Company (1); The Upjohn Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHT
- Run a recall and safety report across every CHT manufacturer
- Watch product code CHT 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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