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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 -5097
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
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
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