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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 K053533
Device Name IMMULITE/IMMULITE 1000 TURBO INTACT PTH
Applicant
Diagnostic Products Corporation
5210 Pacific Concourse Dr.
Los Angeles,  CA  90045
Applicant Contact DEBORAH L MORRIS
Correspondent
Diagnostic Products Corporation
5210 Pacific Concourse Dr.
Los Angeles,  CA  90045
Correspondent Contact DEBORAH L MORRIS
Regulation Number862.1545
Classification Product Code
CEW  
Date Received12/19/2005
Decision Date 02/03/2006
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
Predetermined Change
Control Plan Authorized		 No
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