QUANTA LITE B2 GPI IGA

System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite B2 Gpi Iga.

Pre-market Notification Details

Device IDK973006
510k NumberK973006
Device Name:QUANTA LITE B2 GPI IGA
ClassificationSystem,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
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 CodeMSV  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-13
Decision Date1997-10-20

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