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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 K973900
Device Name TESTOTERONE ELISA
Applicant
KMI DIAGNOSTICS, INC.
818 51ST AVE., N.E.
SUITE 101
MINNEAPOLIS,  MN  55421
Applicant Contact MARK A KOWAL
Correspondent
KMI DIAGNOSTICS, INC.
818 51ST AVE., N.E.
SUITE 101
MINNEAPOLIS,  MN  55421
Correspondent Contact MARK A KOWAL
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received10/14/1997
Decision Date 02/24/1998
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
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