FDA product code IDA: Alcian Blue
IDA is the FDA product code for alcian blue. 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 IDA, from 2 different applicants. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Alcian Blue |
| 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 IDA clearance
Top IDA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 1 | 1983-09-12 |
| Volu Sol Medical Industries | 1 | 1980-05-30 |
Most recent IDA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832496 | Helena Laboratories | BIO SURE STAIN | 1983-09-12 | 47 |
| K801143 | Volu Sol Medical Industries | VOLU-SOL URINARY DICHROME STAIN | 1980-05-30 | 12 |
Recalls for IDA devices
openFDA lists no recalls for product code IDA.
Frequently asked questions
What is FDA product code IDA?
IDA is the FDA product code for alcian blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is IDA?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDA?
Across 2 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most IDA clearances?
Helena Laboratories (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IDA
- Run a recall and safety report across every IDA manufacturer
- Watch product code IDA 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times