Product code DGB— Immunology
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
- Classification name
- Seminal Fluid, Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5800
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DGB
FDA has cleared device under product code DGB, all in 1986, 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 DGB
Recent clearances under product code DGB
Data sourced from openFDA. This site is unofficial and independent of the FDA.