VISTA ANTIGEN SALMONELLA O GROUP D

Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

LEE LABORATORIES, INC.

The following data is part of a premarket notification filed by Lee Laboratories, Inc. with the FDA for Vista Antigen Salmonella O Group D.

Pre-market Notification Details

Device IDK972395
510k NumberK972395
Device Name:VISTA ANTIGEN SALMONELLA O GROUP D
ClassificationAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Applicant LEE LABORATORIES, INC. 1475 HWY. 78, S.W. Grayson,  GA  30221
ContactRobin C Hart
CorrespondentRobin C Hart
LEE LABORATORIES, INC. 1475 HWY. 78, S.W. Grayson,  GA  30221
Product CodeGNC  
CFR Regulation Number866.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-26
Decision Date1997-08-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.