FDA product code ICX: Aniline
ICX is the FDA product code for aniline. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under ICX. The average 510(k) review took 81 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Aniline |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every ICX clearance
Top ICX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rocket Medical Plc | 1 | 1997-10-24 |
Most recent ICX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972867 | Rocket Medical Plc | CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT | 1997-10-24 | 81 |
Recalls for ICX devices
openFDA lists no recalls for product code ICX.
Frequently asked questions
What is FDA product code ICX?
ICX is the FDA product code for aniline. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is ICX?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ICX?
Across 1 cleared submissions the average was 81 days from receipt to decision (median 81).
Which companies have the most ICX clearances?
Rocket Medical Plc (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ICX
- Run a recall and safety report across every ICX manufacturer
- Watch product code ICX 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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