Product code NDR— Clinical Chemistry
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
- Classification name
- Enzyme Immunoassay, Inhibin-A
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code NDR
FDA has cleared device under product code NDR, all in 2000, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code NDR
Recent clearances under product code NDR
Data sourced from openFDA. This site is unofficial and independent of the FDA.