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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K033426
Device Name LIAISON N-TACT PTH
Applicant
DIASORIN, INC.
1951 NORTHWESTERN AVE.
P.O. BOX 285
STILLWATER,  MN  55082
Applicant Contact DAVID M IKEDA
Correspondent
DIASORIN, INC.
1951 NORTHWESTERN AVE.
P.O. BOX 285
STILLWATER,  MN  55082
Correspondent Contact DAVID M IKEDA
Regulation Number862.1545
Classification Product Code
CEW  
Subsequent Product Code
JJX  
Date Received10/27/2003
Decision Date 02/12/2004
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
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