VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

Gram-positive Bacteria And Their Resistance Markers

NANOSPHERE, INC

The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Gram-positive Blood Culture (gc-gp) Nucleic Acid Test.

Pre-market Notification Details

Device IDK122514
510k NumberK122514
Device Name:VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
ClassificationGram-positive Bacteria And Their Resistance Markers
Applicant NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook,  IL  60062
ContactMark Del Vecchio
CorrespondentMark Del Vecchio
NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook,  IL  60062
Product CodePAM  
CFR Regulation Number866.3365 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-17
Decision Date2012-09-19
Summary:summary

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