510(k) K952141
- Device
- Sas Francisella Tularensis Antiserum
- Applicant
- SA SCIENTIFIC, INC.
- 510(k) number
- K952141
- Product code
- GSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-07-21
- Date received
- 1995-05-08
- Regulation
- 866.3280
- Classification name
- Antiserum, Francisella Tularensis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HARBI SHADFAN
- Address
- 4919 Golden Quail San Antonio TX US 78240 78240
FDA Registration Numbers#
- 1649661
Source Documents#
510(k) summary PDF not indicated by FDA