510(k) K952143
- Device
- Sas Brucella Melitensis Antiserum
- Applicant
- SA SCIENTIFIC, INC.
- 510(k) number
- K952143
- Product code
- GSM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-07-21
- Date received
- 1995-05-08
- Regulation
- 866.3085
- Classification name
- Antisera, Fluorescent, Brucella Spp.
- 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#
- 3007208259
- 3007118747
- 3003268355
- 1649661
- 3008191245
- 3007361513
Source Documents#
510(k) summary PDF not indicated by FDA