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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 K955189
Device Name SAS SALMONELLA H Z ANTISERUM
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 Number866.3550
Classification Product Code
GNC  
Date Received11/14/1995
Decision Date 02/02/1996
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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