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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 K961534
Device Name SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)
Applicant
Sa Scientific, Inc.
4919 Golden Quail
San Antonio,  TX  78240
Applicant Contact MARTIN P O'CONNOR
Correspondent
Sa Scientific, Inc.
4919 Golden Quail
San Antonio,  TX  78240
Correspondent Contact MARTIN P O'CONNOR
Regulation Number866.3660
Classification Product Code
GNB  
Date Received04/22/1996
Decision Date 05/20/1996
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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