Product code LOO— Microbiology
AMIZYME-LEISHMANIA SPP. TEST KIT
- Classification name
- Reagent, Leishmanii Serological
- Device class
- Class 1
- Regulation
- 21 CFR 866.3870
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LOO
FDA has cleared devices under product code LOO between 1984 and 2003, 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
- 2003
- 1984
Top applicants under product code LOO
Recent clearances under product code LOO
Data sourced from openFDA. This site is unofficial and independent of the FDA.