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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 K990684
Device Name MODIFICATION OF SAS SERUM/URINE HCG
Applicant
SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO,  TX  78240
Applicant Contact JOSH WESSLING
Correspondent
SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO,  TX  78240
Correspondent Contact JOSH WESSLING
Regulation Number862.1155
Classification Product Code
JHI  
Date Received03/03/1999
Decision Date 05/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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