PanNAT STEC Test

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System

Micronics, Inc

The following data is part of a premarket notification filed by Micronics, Inc with the FDA for Pannat Stec Test.

Pre-market Notification Details

Device IDK173330
510k NumberK173330
Device Name:PanNAT STEC Test
ClassificationGastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Applicant Micronics, Inc 8464 154th Ave NE Redmond,  WA  98052
ContactKaren Hedine
CorrespondentKaren Hedine
Micronics, Inc 8464 154th Ave NE Redmond,  WA  98052
Product CodePCI  
Subsequent Product CodeOOI
Subsequent Product CodePCH
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-23
Decision Date2018-06-01
Summary:summary

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