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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 K923015
Device Name TOTAL T3 CHEMILUMINESCENCE ASSAY
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690 -6130
Applicant Contact RRAMAKIRSHNAN
Correspondent
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690 -6130
Correspondent Contact RRAMAKIRSHNAN
Regulation Number862.1710
Classification Product Code
CDP  
Date Received06/22/1992
Decision Date 09/02/1992
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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