QUANTA LITE(TM) THYROID T ELISA

Thyroglobulin, Antigen, Antiserum, Control

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite(tm) Thyroid T Elisa.

Pre-market Notification Details

Device IDK930486
510k NumberK930486
Device Name:QUANTA LITE(TM) THYROID T ELISA
ClassificationThyroglobulin, Antigen, Antiserum, Control
Applicant INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego,  CA  92121
ContactBrys C Myers
CorrespondentBrys C Myers
INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego,  CA  92121
Product CodeDDC  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-29
Decision Date1993-03-15

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