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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K935863
Device Name SAS(TM) DIRECT MONOCLONAL HCG
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 Number862.1155
Classification Product Code
JHJ  
Subsequent Product Code
JJX  
Date Received12/03/1993
Decision Date 02/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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