Product code GTN— Microbiology
AGGLUTINOTEST-STAPHYLOLISIN
- Classification name
- Antisera, Fluorescent, All Types, Staphylococcus Spp.
- Device class
- Class 1
- Regulation
- 21 CFR 866.3700
- Advisory panel
- Microbiology
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code GTN
FDA has cleared devices under product code GTN between 1979 and 1986, filed by 3 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
- 1986
- 1985
- 1979
Top applicants under product code GTN
Recent clearances under product code GTN
Data sourced from openFDA. This site is unofficial and independent of the FDA.