FDA product code CIY: Radioimmunoassay, Androsterone
CIY is the FDA product code for radioimmunoassay, androsterone. It is a Class I device, regulated under 21 CFR 862.1080 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CIY. The average 510(k) review took 41 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Androsterone |
| Device class | Class I |
| Regulation | 21 CFR 862.1080 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CIY clearance
Top CIY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wien Laboratories, Inc. | 1 | 1977-11-02 |
Most recent CIY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771793 | Wien Laboratories, Inc. | DHEA TEST SET | 1977-11-02 | 41 |
Recalls for CIY devices
openFDA lists no recalls for product code CIY.
Frequently asked questions
What is FDA product code CIY?
CIY is the FDA product code for radioimmunoassay, androsterone. It is a Class I device, regulated under 21 CFR 862.1080 and reviewed by the Clinical Chemistry panel.
What device class is CIY?
Class I, regulation 21 CFR 862.1080. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CIY?
Across 1 cleared submissions the average was 41 days from receipt to decision (median 41).
Which companies have the most CIY clearances?
Wien Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CIY
- Run a recall and safety report across every CIY manufacturer
- Watch product code CIY 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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