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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Angiotensin I And Renin
510(k) Number K011128
Device Name NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
Applicant
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Applicant Contact JIMMY WONG
Correspondent
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Correspondent Contact JIMMY WONG
Regulation Number862.1085
Classification Product Code
CIB  
Subsequent Product Codes
JIT   JJX  
Date Received04/13/2001
Decision Date 09/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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