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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), Agglutination, Brucella Spp.
510(k) Number K952136
Device Name SAS SALMONELLA H B ANTIGEN
Applicant
Sa Scientific, Inc.
4919 Golden Quail
San Antonio,  TX  78240
Applicant Contact HARBI SHADFAN
Correspondent
Sa Scientific, Inc.
4919 Golden Quail
San Antonio,  TX  78240
Correspondent Contact HARBI SHADFAN
Regulation Number866.3085
Classification Product Code
GSO  
Date Received05/08/1995
Decision Date 07/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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