Product Code: DPH FDA class 1 21 CFR 862.3600

Mercury, Atomic Absorption

Clinical Toxicology

The Mercury Atomic Absorption test is a clinical laboratory device that uses atomic absorption spectroscopy to detect and measure mercury concentrations in biological specimens, used in assessing mercury poisoning from environmental, occupational, or dietary exposure. It is a Class 1 device subject to general controls only and does not require premarket notification. The product code is DPH, regulated under 21 CFR 862.3600, within the Clinical Toxicology specialty. It is eligible for third-party review.

510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
5

Research product code DPH in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
DPH
Device Class
FDA class 1
Regulation Number
862.3600
Medical Specialty
Clinical Toxicology
Review Panel
TX
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

Loading...

Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K832933 GOLD FILM MERCURY ANALYZER #511
K781010 MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS