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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K965058
Device Name NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690 -6130
Applicant Contact DAVE D SMITH
Correspondent
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690 -6130
Correspondent Contact DAVE D SMITH
Regulation Number862.1710
Classification Product Code
CDP  
Subsequent Product Code
JIT  
Date Received12/18/1996
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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