Device Classification Name |
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
More FDA Info for this Device |
510(K) Number |
K972391 |
Device Name |
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
Applicant |
LEE LABORATORIES, INC.
1475 HWY. 78, S.W.
GRAYSON, GA 30221 US
Other 510(k) Applications for this Company
|
Contact |
ROBIN C HART
Other 510(k) Applications for this Contact |
Regulation Number |
866.3550
More FDA Info for this Regulation Number |
Classification Product Code |
GNC
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/26/1997 |
Decision Date |
08/25/1997 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
MI - Microbiology |
Review Advisory Committee |
MI - Microbiology |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|