FDA product code IGF: Solution, Formalin-Alcohol-Acetic Acid
IGF is the FDA product code for solution, formalin-alcohol-acetic acid. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IGF. The average 510(k) review took 60 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Formalin-Alcohol-Acetic Acid |
| 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 IGF clearance
Top IGF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-09-11 |
Most recent IGF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842731 | E K Ind., Inc. | FORMALIN-ACETO-ALCOHOL FIXATIVE | 1984-09-11 | 60 |
Recalls for IGF devices
openFDA lists no recalls for product code IGF.
Frequently asked questions
What is FDA product code IGF?
IGF is the FDA product code for solution, formalin-alcohol-acetic acid. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IGF?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IGF?
Across 1 cleared submissions the average was 60 days from receipt to decision (median 60).
Which companies have the most IGF clearances?
E K Ind., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IGF
- Run a recall and safety report across every IGF manufacturer
- Watch product code IGF 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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