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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 K931600
Device Name CHEMILUMINESCENCE FREE T3 IMMUNOASSAY
Applicant
NICHOLS INSTITUTE
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690
Applicant Contact SALVADORE PALOMARES
Correspondent
NICHOLS INSTITUTE
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690
Correspondent Contact SALVADORE PALOMARES
Regulation Number862.1710
Classification Product Code
CDP  
Date Received04/01/1993
Decision Date 09/08/1993
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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