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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Types, Shigella Spp.
510(k) Number K953329
Device Name SAS SHIGELLA BOYDII GROUP C2 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 Number866.3660
Classification Product Code
GNB  
Date Received07/13/1995
Decision Date 08/02/1995
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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