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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cortisol
510(k) Number K010790
Device Name CORTISOL LIA
Applicant
Kmi Diagnostics, Inc.
8201 Central Ave. NE
Suite P
Minneapolis,  MN  55432
Applicant Contact MARK A KOWAL
Correspondent
Kmi Diagnostics, Inc.
8201 Central Ave. NE
Suite P
Minneapolis,  MN  55432
Correspondent Contact MARK A KOWAL
Regulation Number862.1205
Classification Product Code
CGR  
Date Received03/15/2001
Decision Date 01/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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