FDA product code DPH: Mercury, Atomic Absorption
DPH is the FDA product code for mercury, atomic absorption. It is a Class I device, regulated under 21 CFR 862.3600 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DPH, from 2 different applicants. The average 510(k) review took 64 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Mercury, Atomic Absorption |
| Device class | Class I |
| Regulation | 21 CFR 862.3600 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DPH clearance
Top DPH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jerome Instrument Corp. | 1 | 1983-11-25 |
| The Perkin-Elmer Corp. | 1 | 1978-07-27 |
Most recent DPH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832933 | Jerome Instrument Corp. | GOLD FILM MERCURY ANALYZER #511 | 1983-11-25 | 87 |
| K781010 | The Perkin-Elmer Corp. | MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS | 1978-07-27 | 41 |
Recalls for DPH devices
openFDA lists no recalls for product code DPH.
Frequently asked questions
What is FDA product code DPH?
DPH is the FDA product code for mercury, atomic absorption. It is a Class I device, regulated under 21 CFR 862.3600 and reviewed by the Clinical Toxicology panel.
What device class is DPH?
Class I, regulation 21 CFR 862.3600. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPH?
Across 2 cleared submissions the average was 64 days from receipt to decision (median 64).
Which companies have the most DPH clearances?
Jerome Instrument Corp. (1); The Perkin-Elmer Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPH
- Run a recall and safety report across every DPH manufacturer
- Watch product code DPH 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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