510(k) K960162
- Device
- SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM
- Applicant
- SA SCIENTIFIC, INC.
- 510(k) number
- K960162
- Product code
- GRM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-06
- Date received
- 1996-01-11
- Regulation
- 866.3550
- Classification name
- Antisera, 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#
- 9611882
- 3006440892
- 3004569406
- 1119779
- 8020667
- 1025402
- 1649661
- 8010096
- 3005450604
- 2027113
- 3003750284
- 8010383
- 1050190
- 3043196750
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961967 | SAS SALMONELLA O POLY B ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961948 | SAS SALMONELLA O FACTOR 20 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961949 | SAS SALMONELLA O FACTOR 14 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961950 | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961951 | SAS SALMONELLA O FACTOR 6 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961952 | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS | Sa Scientific, Inc. | 1996-06-18 |
| K961953 | SAS SALMONELA H Z24 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961954 | SAS SALMONELLA H Z35 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961955 | SAS SALMONELLA H Z42 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961956 | SAS SALMONELLA H G,M,Q ANTISERMU | Sa Scientific, Inc. | 1996-06-18 |
| K961958 | SAS SALMONELLA H Z4 COMPLEX ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961960 | SAS SALMONELLA H Z4, Z24 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961961 | SAS SALMONELLA H F,G,T ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961962 | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961963 | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
Legacy Summary#
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FDA Review#
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