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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K022683
Device Name SAS BLOOD/SERUM/URINE/URINE HCG
Applicant
Sa Scientific, Inc.
4919 Golden Quail
San Antonio,  TX  78240
Applicant Contact RICARDO R MARTINEZ
Correspondent
Sa Scientific, Inc.
4919 Golden Quail
San Antonio,  TX  78240
Correspondent Contact RICARDO R MARTINEZ
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/12/2002
Decision Date 12/16/2002
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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