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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K974021
Device Name SIGNAL PREGNANCY TEST KIT
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
LCX  
Date Received10/22/1997
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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