FDA product code ICF: Crystal Violet For Histology
ICF is the FDA product code for crystal violet for histology. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under ICF, from 5 different applicants. The average 510(k) review took 36 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Crystal Violet For Histology |
| 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 ICF clearance
Top ICF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 1 | 1986-12-22 |
| American Dade | 1 | 1984-10-01 |
| E K Ind., Inc. | 1 | 1984-08-03 |
| Intl. Remote Imaging Systems | 1 | 1982-06-03 |
| Volu Sol Medical Industries | 1 | 1979-12-18 |
Most recent ICF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864531 | Sigma Diagnostics, Inc. | TISSUE GRAM STAIN | 1986-12-22 | 35 |
| K842537 | American Dade | VON WILLEBRAND FACTOR ANTIGEN SCREEN | 1984-10-01 | 95 |
| K842730 | E K Ind., Inc. | GENTIAN VIOLET | 1984-08-03 | 21 |
| K821503 | Intl. Remote Imaging Systems | IRIS URINE STAIN | 1982-06-03 | 15 |
| K792495 | Volu Sol Medical Industries | VOLU-SOL URINARY SEDIMENT STAIN | 1979-12-18 | 14 |
Recalls for ICF devices
openFDA lists no recalls for product code ICF.
Frequently asked questions
What is FDA product code ICF?
ICF is the FDA product code for crystal violet for histology. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is ICF?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ICF?
Across 5 cleared submissions the average was 36 days from receipt to decision (median 21).
Which companies have the most ICF clearances?
Sigma Diagnostics, Inc. (1); American Dade (1); E K Ind., Inc. (1); Intl. Remote Imaging Systems (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ICF
- Run a recall and safety report across every ICF manufacturer
- Watch product code ICF 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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