FDA product code CFA: Electrode, Ion Specific, Magnesium
CFA is the FDA product code for electrode, ion specific, magnesium. It is a Class I device, regulated under 21 CFR 862.1495 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under CFA, from 2 different applicants. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion Specific, Magnesium |
| Device class | Class I |
| Regulation | 21 CFR 862.1495 |
| 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 CFA clearance
Top CFA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Data Medical Associates, Inc. | 1 | 1986-09-11 |
| Bio-Analytics Laboratories, Inc. | 1 | 1985-05-20 |
Most recent CFA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863267 | Data Medical Associates, Inc. | MAGNESIUM PROCEDURE | 1986-09-11 | 17 |
| K851514 | Bio-Analytics Laboratories, Inc. | ULTRA-VIOLET GLUCOSE REAGENT | 1985-05-20 | 35 |
Recalls for CFA devices
openFDA lists no recalls for product code CFA.
Frequently asked questions
What is FDA product code CFA?
CFA is the FDA product code for electrode, ion specific, magnesium. It is a Class I device, regulated under 21 CFR 862.1495 and reviewed by the Clinical Chemistry panel.
What device class is CFA?
Class I, regulation 21 CFR 862.1495. Typical premarket route: 510(k).
How long does a 510(k) take for product code CFA?
Across 2 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most CFA clearances?
Data Medical Associates, Inc. (1); Bio-Analytics Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CFA
- Run a recall and safety report across every CFA manufacturer
- Watch product code CFA 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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