Product code DJI— Clinical Toxicology
KALLESTAD ANTISERA TO GENTAMICIN
- Classification name
- Antiserum, Gentamicin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3450
- Advisory panel
- Clinical Toxicology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DJI
FDA has cleared device under product code DJI, all in 1981, filed by 1 applicant company. 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.
Top applicants under product code DJI
Recent clearances under product code DJI
Data sourced from openFDA. This site is unofficial and independent of the FDA.