GRM — Antisera, All Groups, Salmonella Spp. Class II
FDA product code GRM covers "Antisera, All Groups, Salmonella Spp.", a Class II medical device regulated under 21 CFR 866.3550. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GRM
- Device Class
- Class II
- Regulation Number
- 866.3550
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K961961 | sa scientific | SAS SALMONELLA H F,G,T ANTISERUM | June 18, 1996 |
| K961948 | sa scientific | SAS SALMONELLA O FACTOR 20 ANTISERUM | June 18, 1996 |
| K961952 | sa scientific | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS | June 18, 1996 |
| K961955 | sa scientific | SAS SALMONELLA H Z42 ANTISERUM | June 18, 1996 |
| K961966 | sa scientific | SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM | June 18, 1996 |
| K961967 | sa scientific | SAS SALMONELLA O POLY B ANTISERUM | June 18, 1996 |
| K961951 | sa scientific | SAS SALMONELLA O FACTOR 6 ANTISERUM | June 18, 1996 |
| K961949 | sa scientific | SAS SALMONELLA O FACTOR 14 ANTISERUM | June 18, 1996 |
| K961950 | sa scientific | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM | June 18, 1996 |
| K961957 | sa scientific | SAS SALMONELLA H Z4, Z32 ANTISERUM | June 18, 1996 |
| K961953 | sa scientific | SAS SALMONELA H Z24 ANTISERUM | June 18, 1996 |
| K961954 | sa scientific | SAS SALMONELLA H Z35 ANTISERUM | June 18, 1996 |
| K961962 | sa scientific | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM | June 18, 1996 |
| K961956 | sa scientific | SAS SALMONELLA H G,M,Q ANTISERMU | June 18, 1996 |
| K961960 | sa scientific | SAS SALMONELLA H Z4, Z24 ANTISERUM | June 18, 1996 |
| K961958 | sa scientific | SAS SALMONELLA H Z4 COMPLEX ANTISERUM | June 18, 1996 |
| K961964 | sa scientific | SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM | June 18, 1996 |
| K961963 | sa scientific | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM | June 18, 1996 |
| K960461 | sa scientific | SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM | March 12, 1996 |
| K960147 | sa scientific | SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM | March 12, 1996 |