510(k) K945839
- Device
- Sas(tm) Qc Antigens For Salmonella Antisera
- Applicant
- SA SCIENTIFIC, INC.
- 510(k) number
- K945839
- Product code
- GRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-07
- Date received
- 1994-11-30
- Regulation
- 866.3550
- Classification name
- Antigens, All Groups, Salmonella 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#
- 1025402
- 3014150341
- 1649661
- 3005360469
- 3024463179
- 2032682
- 9611882
- 1119779
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820996 | SALMONELLA & SHIGELLA GROUPING SERA | Fisher Scientific Co., LLC | 1982-05-03 |