Product code GNC
- Device name
- Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3550
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972395 | VISTA ANTIGEN SALMONELLA O GROUP D | Lee Laboratories, Inc. | 1997-08-25 |
| K972392 | VISTA ANTIGEN SALMONELLA H A | Lee Laboratories, Inc. | 1997-08-25 |
| K972391 | VISTA ANTIGEN SALMONELLA H B | Lee Laboratories, Inc. | 1997-08-25 |
| K972390 | VISTA ANTIGEN SALMONELLA H C | Lee Laboratories, Inc. | 1997-08-25 |
| K972389 | VISTA ANTIGEN SALMONELLA H D | Lee Laboratories, Inc. | 1997-08-25 |
| K972388 | VISTA ANTIGEN SALMONELLA O GROUP C | Lee Laboratories, Inc. | 1997-08-25 |
| K972387 | VISTA ANTIGEN SALMONELLA O GROUP A | Lee Laboratories, Inc. | 1997-08-25 |
| K972386 | VISTA ANTIGEN SALMONELLA O GROUP B | Lee Laboratories, Inc. | 1997-08-25 |
| K955226 | SAS SPICER-EDWARDS 4 ANTISERUM | Sa Scientific, Inc. | 1996-02-13 |
| K955223 | SAS SPICER-EDWARDS 1 ANTISERUM | Sa Scientific, Inc. | 1996-02-13 |
| K955224 | SAS SPICER-EDWARDS 2 ANTISERUM | Sa Scientific, Inc. | 1996-02-13 |
| K955225 | SAS SPICER-EDWARDS 3 ANTISERUM | Sa Scientific, Inc. | 1996-02-13 |
| K955227 | SAS SPICER-EDWARDS EN COMPLEX ANTISERUM | Sa Scientific, Inc. | 1996-02-13 |
| K955228 | SAS SPICER-EDWARDS L COMPLEX | Sa Scientific, Inc. | 1996-02-13 |
| K955220 | SAS SALMONELLA H Z36 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955211 | SAS SALMONELLA H FACTOR 6 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955212 | SAS SALMONELLA H FACTOR 5 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955213 | SAS SALMONELLA H E,N,Z15 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955214 | SAS SALMONELLA E,N,X ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955215 | SAS SALMONELLA H E COMPLEX ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955216 | SAS SALMONELLA H A ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955217 | SAS SALMONELLA H 1,2 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955197 | SAS SALMONELLA H POLY D ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955196 | SAS SALMONELLA H POLY E ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955195 | SAL SALMONELLA H Q ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955218 | SAS SALMONELLA H 1,7 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955219 | SAS SALMONELLA H FACTOR 7 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955221 | SAS SALMONELLA H Z38 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 |
| K955206 | SAS SALMONELLA H K ANTISERUM | Sa Scientific, Inc. | 1996-02-02 |
| K955210 | SAS SALMONELLA H F,G, ANTISERUM | Sa Scientific, Inc. | 1996-02-02 |
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|---|---|---|---|
| 00817978020240 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020080 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020103 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020035 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020028 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020011 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020110 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020226 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020233 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020257 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020264 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020271 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020288 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020295 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020301 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020318 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-17 |
| 00817978020073 | Vision 2 | PRO-LAB, INCORPORATED | 2016-11-16 |
| 00817978020097 | Vision 2 | PRO-LAB, INCORPORATED | 2016-10-24 |
| 00817978020004 | Vision 2 | PRO-LAB, INCORPORATED | 2016-10-20 |
| 05056080500065 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500188 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500157 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500140 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500133 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500126 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500119 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500102 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500096 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500089 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080500072 | NA | REMEL EUROPE LIMITED | 2016-09-24 |