Product code DIJ— Clinical Toxicology
ELVI-AMINOLEVULINIC ACID
- Classification name
- Lead, Delta Amino Levulinic Acid
- Device class
- Class 2
- Regulation
- 21 CFR 862.3550
- Advisory panel
- Clinical Toxicology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DIJ
FDA has cleared devices under product code DIJ between 1980 and 2003, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2003
- 1980
Top applicants under product code DIJ
Recent clearances under product code DIJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.