S. AUREUS/CNS PNA FISH, MODEL KT005

Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus

ADVANDX, INC.

The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for S. Aureus/cns Pna Fish, Model Kt005.

Pre-market Notification Details

Device IDK092166
510k NumberK092166
Device Name:S. AUREUS/CNS PNA FISH, MODEL KT005
ClassificationFish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Applicant ADVANDX, INC. 10A ROESSLER ROAD Woburn,  MA  01801
ContactPaula E Bulger
CorrespondentPaula E Bulger
ADVANDX, INC. 10A ROESSLER ROAD Woburn,  MA  01801
Product CodeNXX  
CFR Regulation Number866.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-21
Decision Date2009-11-23

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