FDA product code IDF: Acid, Fuchsin
IDF is the FDA product code for acid, fuchsin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IDF. The average 510(k) review took 15 days (median 15).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Fuchsin |
| 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 IDF clearance
Top IDF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 1 | 1987-04-29 |
Most recent IDF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871545 | Sigma Diagnostics, Inc. | NEW FUCHSIN SOLUTION | 1987-04-29 | 15 |
Recalls for IDF devices
openFDA lists no recalls for product code IDF.
Frequently asked questions
What is FDA product code IDF?
IDF is the FDA product code for acid, fuchsin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is IDF?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDF?
Across 1 cleared submissions the average was 15 days from receipt to decision (median 15).
Which companies have the most IDF clearances?
Sigma Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IDF
- Run a recall and safety report across every IDF manufacturer
- Watch product code IDF 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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