QUANTA LITE(TM) IGG (HRP)

System, Test, Anticardiolipin Immunological

INOVA DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK946034
510k NumberK946034
Device Name:QUANTA LITE(TM) IGG (HRP)
ClassificationSystem, Test, Anticardiolipin Immunological
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 CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-09
Decision Date1995-07-18

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