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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Sickle Cell
510(k) Number K960947
Device Name SAS SICKLE CELL TEST
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 Number864.7825
Classification Product Code
GHM  
Date Received03/08/1996
Decision Date 07/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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