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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 K150879
Device Name LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
DiaSorin Inc.
1951 Northwestern Avenue
Stillwater,  MN  55082 -1482
Applicant Contact John Walter
DiaSorin Inc.
1951 Northwestern Avenue
Stillwater,  MN  55082 -1482
Correspondent Contact Carol A DePouw
Regulation Number862.1545
Classification Product Code
Subsequent Product Code
Date Received04/01/2015
Decision Date 06/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls