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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
510(k) Number K972388
Device Name VISTA ANTIGEN SALMONELLA O GROUP C
Applicant
Lee Laboratories, Inc.
1475 Hwy. 78, SW
Grayson,  GA  30221
Applicant Contact ROBIN C HART
Correspondent
Lee Laboratories, Inc.
1475 Hwy. 78, SW
Grayson,  GA  30221
Correspondent Contact ROBIN C HART
Regulation Number866.3550
Classification Product Code
GNC  
Date Received06/26/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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