The following data is part of a premarket notification filed by Lee Laboratories, Inc. with the FDA for Vista Antigen Salmonella H D.
Device ID | K972389 |
510k Number | K972389 |
Device Name: | VISTA ANTIGEN SALMONELLA H 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 |