FDA product code IFB: Cytocentrifuge
IFB is the FDA product code for cytocentrifuge. It is a Class I device, regulated under 21 CFR 864.3300 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under IFB, from 3 different applicants. The average 510(k) review took 35 days (median 27). FDA has posted 2 recalls for IFB devices.
Classification
| Field | Value |
|---|---|
| Device name | Cytocentrifuge |
| Device class | Class I |
| Regulation | 21 CFR 864.3300 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IFB clearance
Top IFB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 1 | 1985-06-10 |
| Cytochem, Inc. | 1 | 1981-04-23 |
| Robert C. Leif, Ph.D. | 1 | 1979-11-30 |
Most recent IFB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852117 | Miles Laboratories, Inc. | CYTO-TEK CENTRIFUGE | 1985-06-10 | 26 |
| K810848 | Cytochem, Inc. | CYTOBUCKET MODEL 1024 | 1981-04-23 | 27 |
| K792032 | Robert C. Leif, Ph.D. | LEIF CENTRIFUGAL CYTOLOGY BUCKET | 1979-11-30 | 51 |
Recalls for IFB devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-04.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code IFB?
IFB is the FDA product code for cytocentrifuge. It is a Class I device, regulated under 21 CFR 864.3300 and reviewed by the Pathology panel.
What device class is IFB?
Class I, regulation 21 CFR 864.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IFB?
Across 3 cleared submissions the average was 35 days from receipt to decision (median 27).
Which companies have the most IFB clearances?
Miles Laboratories, Inc. (1); Cytochem, Inc. (1); Robert C. Leif, Ph.D. (1).
Have IFB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code IFB
- Run a recall and safety report across every IFB manufacturer
- Watch product code IFB 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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