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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 K040813
Device Name NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
Applicant
Nichols Institute Diagnostics
1311 Calle Batido
San Clemente,  CA  92673
Applicant Contact JIMMY WONG
Correspondent
Nichols Institute Diagnostics
1311 Calle Batido
San Clemente,  CA  92673
Correspondent Contact JIMMY WONG
Regulation Number862.1545
Classification Product Code
CEW  
Date Received03/30/2004
Decision Date 06/08/2004
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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