The following data is part of a premarket notification filed by Lee Laboratories, Inc. with the FDA for Vista Antigen Salmonella O Group D.
| Device ID | K972395 |
| 510k Number | K972395 |
| Device Name: | VISTA ANTIGEN SALMONELLA O GROUP D |
| Classification | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
| Applicant | LEE LABORATORIES, INC. 1475 HWY. 78, S.W. Grayson, GA 30221 |
| Contact | Robin C Hart |
| Correspondent | Robin C Hart LEE LABORATORIES, INC. 1475 HWY. 78, S.W. Grayson, GA 30221 |
| Product Code | GNC |
| CFR Regulation Number | 866.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-08-25 |