NICHOLS ADVANTAGE THYROGLOB

System, Test, Thyroglobulin

NICHOLS INSTITUTE DIAGNOSTICS

The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Thyroglob.

Pre-market Notification Details

Device IDK002888
510k NumberK002888
Device Name:NICHOLS ADVANTAGE THYROGLOB
ClassificationSystem, Test, Thyroglobulin
Applicant NICHOLS INSTITUTE DIAGNOSTICS 33047 CALLE AVIADOR San Juan Capistrano,  CA  92675
ContactJimmy Wong
CorrespondentJimmy Wong
NICHOLS INSTITUTE DIAGNOSTICS 33047 CALLE AVIADOR San Juan Capistrano,  CA  92675
Product CodeMSW  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-15
Decision Date2000-10-20

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