FDA product code IGN: Fluid, Bouin'S
IGN is the FDA product code for fluid, bouin's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under IGN, from 2 different applicants. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Fluid, Bouin'S |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top IGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1983-11-14 |
| Volu Sol Medical Industries | 1 | 1982-08-05 |
Most recent IGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833515 | Sigma Chemical Co. | BOUINS SOLUTION | 1983-11-14 | 34 |
| K822129 | Volu Sol Medical Industries | VOLU-SOL BOVINS FIXATIVE | 1982-08-05 | 17 |
Recalls for IGN devices
openFDA lists no recalls for product code IGN.
Frequently asked questions
What is FDA product code IGN?
IGN is the FDA product code for fluid, bouin's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IGN?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IGN?
Across 2 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most IGN clearances?
Sigma Chemical Co. (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IGN
- Run a recall and safety report across every IGN manufacturer
- Watch product code IGN 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.