GRAM-NEGATIVE QUICKFISH BC

Kit, Identification, Enterobacteriaceae

ADVANDX, INC.

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

Pre-market Notification Details

Device IDK123418
510k NumberK123418
Device Name:GRAM-NEGATIVE QUICKFISH BC
ClassificationKit, Identification, Enterobacteriaceae
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 CodeJSS  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-06
Decision Date2013-07-21

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