QUANTA LITE REBELLA IGG

Enzyme Linked Immunoabsorbent Assay, Rubella

INOVA DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK971304
510k NumberK971304
Device Name:QUANTA LITE REBELLA IGG
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
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 CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-08
Decision Date1998-01-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.