FDA product code JFN: Atomic Absorption, Calcium
JFN is the FDA product code for atomic absorption, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JFN, from 2 different applicants. The average 510(k) review took 75 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Atomic Absorption, 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 JFN clearance
Top JFN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 2 | 1991-11-19 |
| Creative Scientific Technology, Inc. | 1 | 1987-09-02 |
Most recent JFN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914510 | Beckman Instruments, Inc. | CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY | 1991-11-19 | 41 |
| K871903 | Creative Scientific Technology, Inc. | QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) | 1987-09-02 | 110 |
| K770570 | Beckman Instruments, Inc. | CALCIUM/MAGNESIUM ANALYZER | 1977-06-08 | 75 |
Recalls for JFN devices
openFDA lists no recalls for product code JFN.
Frequently asked questions
What is FDA product code JFN?
JFN is the FDA product code for atomic absorption, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is JFN?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFN?
Across 3 cleared submissions the average was 75 days from receipt to decision (median 75).
Which companies have the most JFN clearances?
Beckman Instruments, Inc. (2); Creative Scientific Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JFN
- Run a recall and safety report across every JFN manufacturer
- Watch product code JFN 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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