FDA product code JFO: Fluorometric, Calcium
JFO is the FDA product code for fluorometric, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JFO. The average 510(k) review took 109 days (median 109). FDA has posted 1 recall for JFO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fluorometric, Calcium |
| Device class | Class II |
| Regulation | 21 CFR 862.1145 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JFO clearance
Top JFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel Co. | 1 | 1992-06-19 |
Most recent JFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920974 | Remel Co. | BACTIDROP ACRIDINE ORANGE | 1992-06-19 | 109 |
Recalls for JFO devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-09-20.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code JFO?
JFO is the FDA product code for fluorometric, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is JFO?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFO?
Across 1 cleared submissions the average was 109 days from receipt to decision (median 109).
Which companies have the most JFO clearances?
Remel Co. (1).
Have JFO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-09-20.
Next steps
- Run an FDA pathway report with predicate devices for product code JFO
- Run a recall and safety report across every JFO manufacturer
- Watch product code JFO 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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