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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K030628
Device Name SAS RSV CONTROL KIT
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 Number862.1660
Classification Product Code
JJX  
Date Received02/27/2003
Decision Date 03/17/2003
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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