FDA product code CEL: Ammonium Molybdate And Ammonium Vanadate, Phospholipids
CEL is the FDA product code for ammonium molybdate and ammonium vanadate, phospholipids. It is a Class I device, regulated under 21 CFR 862.1575 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under CEL, from 3 different applicants. The average 510(k) review took 65 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Ammonium Molybdate And Ammonium Vanadate, Phospholipids |
| Device class | Class I |
| Regulation | 21 CFR 862.1575 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CEL clearance
Top CEL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kamiya Biomedical Co. | 1 | 1991-01-30 |
| The DU Pont Co. | 1 | 1989-01-24 |
| Wako Pure Chemical Industries, Ltd. | 1 | 1980-06-30 |
Most recent CEL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K905829 | Kamiya Biomedical Co. | DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS | 1991-01-30 | 30 |
| K884169 | The DU Pont Co. | DU PONT ANALYST THYROID ROTOR | 1989-01-24 | 112 |
| K801076 | Wako Pure Chemical Industries, Ltd. | WAKO PHOSPHOLIPIDS TEST | 1980-06-30 | 54 |
Recalls for CEL devices
openFDA lists no recalls for product code CEL.
Frequently asked questions
What is FDA product code CEL?
CEL is the FDA product code for ammonium molybdate and ammonium vanadate, phospholipids. It is a Class I device, regulated under 21 CFR 862.1575 and reviewed by the Clinical Chemistry panel.
What device class is CEL?
Class I, regulation 21 CFR 862.1575. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEL?
Across 3 cleared submissions the average was 65 days from receipt to decision (median 54).
Which companies have the most CEL clearances?
Kamiya Biomedical Co. (1); The DU Pont Co. (1); Wako Pure Chemical Industries, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CEL
- Run a recall and safety report across every CEL manufacturer
- Watch product code CEL 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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