Product Code: DIJ
FDA class 2
21 CFR 862.3550
Lead, Delta Amino Levulinic Acid
Clinical Toxicology
The Lead Delta Amino Levulinic Acid test is a laboratory assay used to measure delta-aminolevulinic acid (ALA) in urine as a biomarker of lead exposure, since elevated ALA is a consequence of lead's inhibition of heme biosynthesis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3550 within the Clinical Toxicology specialty. No special risk flags apply to this device.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
23
Research product code DIJ 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
- DIJ
- Device Class
- FDA class 2
- Regulation Number
- 862.3550
- 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.