KRONUS OPTIQUANT THYROGLOBULIN KIT

System, Test, Thyroglobulin

UNCHANGED

The following data is part of a premarket notification filed by Unchanged with the FDA for Kronus Optiquant Thyroglobulin Kit.

Pre-market Notification Details

Device IDK991720
510k NumberK991720
Device Name:KRONUS OPTIQUANT THYROGLOBULIN KIT
ClassificationSystem, Test, Thyroglobulin
Applicant UNCHANGED 1000 CALLE AMANECER San Clemente,  CA  92673
ContactA.p. Doerscchuk
CorrespondentA.p. Doerscchuk
UNCHANGED 1000 CALLE AMANECER San Clemente,  CA  92673
Product CodeMSW  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-20
Decision Date1999-08-09

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