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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameBAYER IMMUNO 1 SYSTEM  
Document NumberK963080
Parent Document NumberK963080
Analyte NameTestosterone
Analyte SpecialtyEndocrinology
ComplexityMODERATE
Effective Date08/21/1998
Device Classification Name Radioimmunoassay, Testosterones And Dihydrotestosterone
510(k) Number K963080
Device Name TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Code
JIS  
Date Received08/08/1996
Decision Date 09/27/1996
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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