FDA product code IFI: Sprays, Synthetic, Smear
IFI is the FDA product code for sprays, synthetic, smear. 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 IFI. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Sprays, Synthetic, Smear |
| 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 IFI clearance
Top IFI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Laboratory Products, Inc. | 1 | 1980-12-30 |
Most recent IFI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K803050 | Laboratory Products, Inc. | SPRAY, SYNTHETIC SMEAR | 1980-12-30 | 28 |
Recalls for IFI devices
openFDA lists no recalls for product code IFI.
Frequently asked questions
What is FDA product code IFI?
IFI is the FDA product code for sprays, synthetic, smear. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IFI?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IFI?
Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most IFI clearances?
Laboratory Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IFI
- Run a recall and safety report across every IFI manufacturer
- Watch product code IFI 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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