GNC — Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. Class II
FDA product code GNC covers "Antigens, Febrile, Slide And Tube, 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
- GNC
- 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 |
|---|---|---|---|
| K972395 | lee laboratories | VISTA ANTIGEN SALMONELLA O GROUP D | August 25, 1997 |
| K972387 | lee laboratories | VISTA ANTIGEN SALMONELLA O GROUP A | August 25, 1997 |
| K972391 | lee laboratories | VISTA ANTIGEN SALMONELLA H B | August 25, 1997 |
| K972386 | lee laboratories | VISTA ANTIGEN SALMONELLA O GROUP B | August 25, 1997 |
| K972389 | lee laboratories | VISTA ANTIGEN SALMONELLA H D | August 25, 1997 |
| K972392 | lee laboratories | VISTA ANTIGEN SALMONELLA H A | August 25, 1997 |
| K972388 | lee laboratories | VISTA ANTIGEN SALMONELLA O GROUP C | August 25, 1997 |
| K972390 | lee laboratories | VISTA ANTIGEN SALMONELLA H C | August 25, 1997 |
| K955224 | sa scientific | SAS SPICER-EDWARDS 2 ANTISERUM | February 13, 1996 |
| K955227 | sa scientific | SAS SPICER-EDWARDS EN COMPLEX ANTISERUM | February 13, 1996 |
| K955228 | sa scientific | SAS SPICER-EDWARDS L COMPLEX | February 13, 1996 |
| K955223 | sa scientific | SAS SPICER-EDWARDS 1 ANTISERUM | February 13, 1996 |
| K955226 | sa scientific | SAS SPICER-EDWARDS 4 ANTISERUM | February 13, 1996 |
| K955225 | sa scientific | SAS SPICER-EDWARDS 3 ANTISERUM | February 13, 1996 |
| K955217 | sa scientific | SAS SALMONELLA H 1,2 ANTISERUM | February 7, 1996 |
| K955218 | sa scientific | SAS SALMONELLA H 1,7 ANTISERUM | February 7, 1996 |
| K955211 | sa scientific | SAS SALMONELLA H FACTOR 6 ANTISERUM | February 7, 1996 |
| K955220 | sa scientific | SAS SALMONELLA H Z36 ANTISERUM | February 7, 1996 |
| K955197 | sa scientific | SAS SALMONELLA H POLY D ANTISERUM | February 7, 1996 |
| K955212 | sa scientific | SAS SALMONELLA H FACTOR 5 ANTISERUM | February 7, 1996 |