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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
Recalls CDRH Recalls
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