The following data is part of a premarket notification filed by Lee Laboratories, Inc. with the FDA for Vista Antigen Brucella Melitensis.
| Device ID | K972396 |
| 510k Number | K972396 |
| Device Name: | VISTA ANTIGEN BRUCELLA MELITENSIS |
| Classification | Antigens (febrile), Agglutination, Brucella 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 | GSO |
| CFR Regulation Number | 866.3085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-08-25 |