C. ALBICANS/C. GLABRATA PNA FISH

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

ADVANDX, INC.

The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for C. Albicans/c. Glabrata Pna Fish.

Pre-market Notification Details

Device IDK092784
510k NumberK092784
Device Name:C. ALBICANS/C. GLABRATA PNA FISH
ClassificationFish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Applicant ADVANDX, INC. 10A ROESSLER ROAD Woburn,  MA  01801
ContactHenrik Stender
CorrespondentHenrik Stender
ADVANDX, INC. 10A ROESSLER ROAD Woburn,  MA  01801
Product CodeNZS  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-10
Decision Date2010-03-12

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