Product code LEE— Hematology
COUNT-10 STAIN
- Classification name
- Stains, Dye Solution
- Device class
- Class 1
- Regulation
- 21 CFR 864.1850
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LEE
FDA has cleared device under product code LEE, all in 1982, 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 LEE
Recent clearances under product code LEE
Data sourced from openFDA. This site is unofficial and independent of the FDA.