VIDAS RUB IGG

Enzyme Linked Immunoabsorbent Assay, Rubella

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Rub Igg.

Pre-market Notification Details

Device IDK080766
510k NumberK080766
Device Name:VIDAS RUB IGG
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactNikita S Mapp
CorrespondentNikita S Mapp
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-18
Decision Date2008-12-23
Summary:summary

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