FDA product code ICC: Eosin B
ICC is the FDA product code for eosin b. 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 ICC. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Eosin B |
| 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 ICC clearance
Top ICC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Harleco | 1 | 1981-04-08 |
Most recent ICC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810684 | Harleco | HEMOCOLOR STAIN SET | 1981-04-08 | 26 |
Recalls for ICC devices
openFDA lists no recalls for product code ICC.
Frequently asked questions
What is FDA product code ICC?
ICC is the FDA product code for eosin b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is ICC?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ICC?
Across 1 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most ICC clearances?
Harleco (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ICC
- Run a recall and safety report across every ICC manufacturer
- Watch product code ICC 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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