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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,Alpha-Fetoprotein For Testicular Cancer
510(k) Number K851891
Device Name TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
Applicant
Richard Scott Elliott
1520 24th. St. NE
Salem,  OR  97301
Applicant Contact SCOTT ELLIOT
Correspondent
Richard Scott Elliott
1520 24th. St. NE
Salem,  OR  97301
Correspondent Contact SCOTT ELLIOT
Regulation Number866.6010
Classification Product Code
LOJ  
Date Received04/30/1985
Decision Date 07/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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