Product code DBT— Immunology
MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
- Classification name
- Factor Xiii A, S, Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5330
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DBT
FDA has cleared device under product code DBT, all in 1987, 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 DBT
Recent clearances under product code DBT
Data sourced from openFDA. This site is unofficial and independent of the FDA.