FDA product code CHO: Radioimmunoassay, Cyclic Amp
CHO is the FDA product code for radioimmunoassay, cyclic amp. It is a Class II device, regulated under 21 CFR 862.1230 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under CHO, from 5 different applicants. The average 510(k) review took 58 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Cyclic Amp |
| Device class | Class II |
| Regulation | 21 CFR 862.1230 |
| 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 CHO clearance
Top CHO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno Nuclear Corp. | 2 | 1985-03-05 |
| Amersham Corp. | 1 | 1986-03-14 |
| New England Nuclear | 1 | 1984-06-14 |
| King Diagnostics, Inc. | 1 | 1981-07-10 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1981-05-27 |
Most recent CHO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860253 | Amersham Corp. | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) | 1986-03-14 | 49 |
| K844135 | Immuno Nuclear Corp. | PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU | 1985-03-05 | 133 |
| K841478 | New England Nuclear | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | 1984-06-14 | 66 |
| K823504 | Immuno Nuclear Corp. | CYCLIC ADENOSINE MONOPHOSHATE BY RADIO | 1983-01-28 | 65 |
| K811746 | King Diagnostics, Inc. | KING DIAGNOSTICS CHOLESTEROL-FE TEST | 1981-07-10 | 18 |
Recalls for CHO devices
openFDA lists no recalls for product code CHO.
Frequently asked questions
What is FDA product code CHO?
CHO is the FDA product code for radioimmunoassay, cyclic amp. It is a Class II device, regulated under 21 CFR 862.1230 and reviewed by the Clinical Chemistry panel.
What device class is CHO?
Class II, regulation 21 CFR 862.1230. Typical premarket route: 510(k).
How long does a 510(k) take for product code CHO?
Across 6 cleared submissions the average was 58 days from receipt to decision (median 57).
Which companies have the most CHO clearances?
Immuno Nuclear Corp. (2); Amersham Corp. (1); New England Nuclear (1); King Diagnostics, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHO
- Run a recall and safety report across every CHO manufacturer
- Watch product code CHO 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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