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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cortisol
510(k) Number K984520
Device Name NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
Applicant
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Applicant Contact JIM WONG
Correspondent
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Correspondent Contact JIM WONG
Regulation Number862.1205
Classification Product Code
CGR  
Date Received12/21/1998
Decision Date 02/05/1999
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
Predetermined Change
Control Plan Authorized		 No
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