Product code DET— Immunology
LD-1
- Classification name
- Lactic Dehydrogenase, Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5560
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DET
FDA has cleared device under product code DET, all in 1990, 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 DET
Recent clearances under product code DET
Data sourced from openFDA. This site is unofficial and independent of the FDA.