QUANTA Flash Calprotectin And Fecal Extraction Device

Calprotectin, Fecal

Inova Diagnostics, Inc.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Calprotectin And Fecal Extraction Device.

Pre-market Notification Details

Device IDK180971
510k NumberK180971
Device Name:QUANTA Flash Calprotectin And Fecal Extraction Device
ClassificationCalprotectin, Fecal
Applicant Inova Diagnostics, Inc. 9900 Old Grove Road San Diego,  CA  92131 -1638
ContactRoger Albesa
CorrespondentRoger Albesa
Inova Diagnostics, Inc. 9900 Old Grove Road San Diego,  CA  92131 -1638
Product CodeNXO  
CFR Regulation Number866.5180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-13
Decision Date2018-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950846833 K180971 000

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