VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448

Immunoassay Method, Troponin Subunit

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Troponin I Ultra (tniu) Assay, Model 30 448.

Pre-market Notification Details

Device IDK063243
510k NumberK063243
Device Name:VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
ClassificationImmunoassay Method, Troponin Subunit
Applicant BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2320
ContactNikita S Mapp
CorrespondentNikita S Mapp
BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2320
Product CodeMMI  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-26
Decision Date2007-12-14
Summary:summary

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