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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 K013992
Device Name NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
33051 CALLE AVIADOR
SAN JUAN CAPISTRANO,  CA  92675
Applicant Contact ROBERT SCHMIDT
Correspondent
CALIFORNIA DEPARTMENT OF HEALTH SERVICES
P.O. BOX 942732 (MS-357)
SACRAMENTO,  CA  94234 -7320
Correspondent Contact RAYMOND WILSON
Regulation Number862.1545
Classification Product Code
CEW  
Date Received12/04/2001
Decision Date 12/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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