FDA product code IGM: Solution, Carnoy'S
IGM is the FDA product code for solution, carnoy's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under IGM, from 3 different applicants. The average 510(k) review took 30 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Carnoy'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 |
Compare with all 510(k) review times · Search every IGM clearance
Top IGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-09-07 |
| Volu Sol Medical Industries | 1 | 1982-08-05 |
| Marion Laboratories, Inc. | 1 | 1979-05-15 |
Most recent IGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842737 | E K Ind., Inc. | CARNOY'S SOLUTION | 1984-09-07 | 56 |
| K822126 | Volu Sol Medical Industries | VOLU-SOL CARNOY FLUID | 1982-08-05 | 17 |
| K790815 | Marion Laboratories, Inc. | CULTURETTE BRAND PVA | 1979-05-15 | 18 |
Recalls for IGM devices
openFDA lists no recalls for product code IGM.
Frequently asked questions
What is FDA product code IGM?
IGM is the FDA product code for solution, carnoy's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IGM?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IGM?
Across 3 cleared submissions the average was 30 days from receipt to decision (median 18).
Which companies have the most IGM clearances?
E K Ind., Inc. (1); Volu Sol Medical Industries (1); Marion Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IGM
- Run a recall and safety report across every IGM manufacturer
- Watch product code IGM 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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