FDA product code ICN: Biebrich Scarlet
ICN is the FDA product code for biebrich scarlet. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under ICN, from 2 different applicants. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Biebrich Scarlet |
| 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 ICN clearance
Top ICN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1983-10-31 |
| Volu Sol Medical Industries | 1 | 1982-08-05 |
Most recent ICN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833273 | Sigma Chemical Co. | MASSON TRICHROME STAIN HT15 | 1983-10-31 | 40 |
| K822128 | Volu Sol Medical Industries | VOLU-SOL SINGLE DIFFERENTIAL STAIN | 1982-08-05 | 17 |
Recalls for ICN devices
openFDA lists no recalls for product code ICN.
Frequently asked questions
What is FDA product code ICN?
ICN is the FDA product code for biebrich scarlet. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is ICN?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ICN?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most ICN clearances?
Sigma Chemical Co. (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ICN
- Run a recall and safety report across every ICN manufacturer
- Watch product code ICN 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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