FDA product code IGE: Solution, Formalin Ammonium Bromide
IGE is the FDA product code for solution, formalin ammonium bromide. 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 IGE, from 2 different applicants. The average 510(k) review took 74 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Formalin Ammonium Bromide |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IGE clearance
Top IGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Busse Hospital Disposables, Inc. | 1 | 1995-05-30 |
| Anatech, Ltd. | 1 | 1984-08-28 |
Most recent IGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950560 | Busse Hospital Disposables, Inc. | SALINE SOLUTINE, STERILE | 1995-05-30 | 111 |
| K842862 | Anatech, Ltd. | CB FORMALIN | 1984-08-28 | 36 |
Recalls for IGE devices
openFDA lists no recalls for product code IGE.
Frequently asked questions
What is FDA product code IGE?
IGE is the FDA product code for solution, formalin ammonium bromide. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IGE?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IGE?
Across 2 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most IGE clearances?
Busse Hospital Disposables, Inc. (1); Anatech, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IGE
- Run a recall and safety report across every IGE manufacturer
- Watch product code IGE 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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