DPH · Mercury, Atomic Absorption
Clinical Toxicology · 21 CFR 862.3600 · Class 1
Overview
| Product Code | DPH |
|---|---|
| Device Name | Mercury, Atomic Absorption |
| Regulation | 21 CFR 862.3600 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A mercury test system is a device intended to measure mercury, a heavy metal, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of mercury poisoning.
Classification Rationale
Class I.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832933 | GOLD FILM MERCURY ANALYZER #511 | Jerome Instrument Corp. | Nov 25, 1983 | SESE |
| K781010 | MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS | The Perkin-Elmer Corp. | Jul 27, 1978 | SESE |
Top Applicants
- Jerome Instrument Corp. — 1 clearance
- The Perkin-Elmer Corp. — 1 clearance
