Product code KJK— Hematology
AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
- Classification name
- Auramine O
- Device class
- Class 1
- Regulation
- 21 CFR 864.1850
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code KJK
FDA has cleared devices under product code KJK between 1981 and 1985, filed by 2 applicant companies. 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.
Clearances per year
- 1985
- 1981
Top applicants under product code KJK
Recent clearances under product code KJK
Data sourced from openFDA. This site is unofficial and independent of the FDA.