FDA product code CER: 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
CER is the FDA product code for 2,4-dinitrophenylhydrazine, lactate dehydrogenase. It is a Class II device, regulated under 21 CFR 862.1440 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CER. The average 510(k) review took 11 days (median 11).
Classification
| Field | Value |
|---|---|
| Device name | 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase |
| Device class | Class II |
| Regulation | 21 CFR 862.1440 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CER clearance
Top CER applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volu Sol Medical Industries | 1 | 1979-12-07 |
Most recent CER clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792416 | Volu Sol Medical Industries | ELVI TOTAL PROTEINS | 1979-12-07 | 11 |
Recalls for CER devices
openFDA lists no recalls for product code CER.
Frequently asked questions
What is FDA product code CER?
CER is the FDA product code for 2,4-dinitrophenylhydrazine, lactate dehydrogenase. It is a Class II device, regulated under 21 CFR 862.1440 and reviewed by the Clinical Chemistry panel.
What device class is CER?
Class II, regulation 21 CFR 862.1440. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CER?
Across 1 cleared submissions the average was 11 days from receipt to decision (median 11).
Which companies have the most CER clearances?
Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CER
- Run a recall and safety report across every CER manufacturer
- Watch product code CER 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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