FDA product code ICH: Congo Red
ICH is the FDA product code for congo red. 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 ICH. The average 510(k) review took 18 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Congo Red |
| 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 ICH clearance
Top ICH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1984-03-12 |
Most recent ICH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840798 | Sigma Chemical Co. | AMYLOID STAIN, CONGO RED HT 60 | 1984-03-12 | 18 |
Recalls for ICH devices
openFDA lists no recalls for product code ICH.
Frequently asked questions
What is FDA product code ICH?
ICH is the FDA product code for congo red. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is ICH?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ICH?
Across 1 cleared submissions the average was 18 days from receipt to decision (median 18).
Which companies have the most ICH clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ICH
- Run a recall and safety report across every ICH manufacturer
- Watch product code ICH 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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