510(k) K972386
- Device
- VISTA ANTIGEN SALMONELLA O GROUP B
- Applicant
- LEE LABORATORIES, INC.
- 510(k) number
- K972386
- Product code
- GNC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-25
- Date received
- 1997-06-26
- Regulation
- 866.3550
- Classification name
- Antigens, Febrile, Slide And Tube, 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
- ROBIN C HART
- Address
- 1475 Hwy. 78, SW Grayson GA US 30221 30221
FDA Registration Numbers#
- 3003750284
- 1649661
- 3005984081
- 2250030
- 2029372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNC #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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