Product code LDN— Clinical Toxicology
AMIKACIN REAGENT TEST KIT
- Classification name
- Enzymatic Radiochemical Assay, Amikacin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3035
- Advisory panel
- Clinical Toxicology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code LDN
FDA has cleared devices under product code LDN between 1982 and 1984, 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
- 1984
- 1983
- 1982
Top applicants under product code LDN
Recent clearances under product code LDN
Data sourced from openFDA. This site is unofficial and independent of the FDA.