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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
510(k) Number K973897
Device Name DHEA-S
Applicant
Kmi Diagnostics, Inc.
818 51st Ave., NE
Suite 101
Minneapolis,  MN  55421
Applicant Contact MARK A KOWAL
Correspondent
Kmi Diagnostics, Inc.
818 51st Ave., NE
Suite 101
Minneapolis,  MN  55421
Correspondent Contact MARK A KOWAL
Regulation Number862.1245
Classification Product Code
JKC  
Date Received10/14/1997
Decision Date 11/13/1997
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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