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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Vitamin D
510(k) Number K014030
Device Name 1,25-DIHYDROXYVITAMIN D125I RIA
Applicant
Diasorin, Inc.
1951 Northwestern Ave., P.O. Box 285
Stillwater,  MN  55082 -0285
Applicant Contact DAVID IKEDA
Correspondent
Diasorin, Inc.
1951 Northwestern Ave., P.O. Box 285
Stillwater,  MN  55082 -0285
Correspondent Contact DAVID IKEDA
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Code
LCI  
Date Received12/06/2001
Decision Date 03/26/2002
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
Recalls CDRH Recalls
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