Product code GSK— Microbiology
SAS FRANCISELLA TULARENSIS ANTISERUM
- Classification name
- Antiserum, Francisella Tularensis
- Device class
- Class 2
- Regulation
- 21 CFR 866.3280
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GSK
FDA has cleared device under product code GSK, all in 1995, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code GSK
Recent clearances under product code GSK
Data sourced from openFDA. This site is unofficial and independent of the FDA.