ENTEROCOCCUS QUICKFISH BC

Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

ADVANDX, INC.

The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for Enterococcus Quickfish Bc.

Pre-market Notification Details

Device IDK121991
510k NumberK121991
Device Name:ENTEROCOCCUS QUICKFISH BC
ClassificationFish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Applicant ADVANDX, INC. 400 TRADECENTER SUITE 6990 Woburn,  MA  01801
ContactBenjamin S Crystal
CorrespondentBenjamin S Crystal
ADVANDX, INC. 400 TRADECENTER SUITE 6990 Woburn,  MA  01801
Product CodeOAH  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-06
Decision Date2013-01-07

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