FDA product code CEQ: Molybdenum Blue Method, Phospholipids
CEQ is the FDA product code for molybdenum blue method, phospholipids. It is a Class I device, regulated under 21 CFR 862.1575 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CEQ. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Molybdenum Blue Method, Phospholipids |
| Device class | Class I |
| Regulation | 21 CFR 862.1575 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top CEQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. D. Assoc. | 1 | 1986-09-09 |
Most recent CEQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863071 | J. D. Assoc. | PHOSPHOLIPIDS-E | 1986-09-09 | 28 |
Recalls for CEQ devices
openFDA lists no recalls for product code CEQ.
Frequently asked questions
What is FDA product code CEQ?
CEQ is the FDA product code for molybdenum blue method, phospholipids. It is a Class I device, regulated under 21 CFR 862.1575 and reviewed by the Clinical Chemistry panel.
What device class is CEQ?
Class I, regulation 21 CFR 862.1575. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEQ?
Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most CEQ clearances?
J. D. Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CEQ
- Run a recall and safety report across every CEQ manufacturer
- Watch product code CEQ 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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