Product code DKD— Clinical Toxicology
BIO-MONITOR GENTAMICIN
- Classification name
- Bacillus Subtilis, Microbiological Assay, Gentamicin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3450
- Advisory panel
- Clinical Toxicology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DKD
FDA has cleared devices under product code DKD between 1977 and 1978, 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
- 1978
- 1977
Top applicants under product code DKD
Recent clearances under product code DKD
Data sourced from openFDA. This site is unofficial and independent of the FDA.