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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Positive And Negative Febrile Antigen Control Serum
510(k) Number K952145
Device Name SAS FEBRILE POSITIVE & NEGATIVE CONTROL 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 Number866.3085
Classification Product Code
GSN  
Date Received05/08/1995
Decision Date 07/18/1995
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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