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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gastrointestinal bacterial panel multiplex nucleic acid-based assay system
510(k) Number K173330
Device Name PanNAT STEC Test
Micronics, Inc
8464 154th Ave
Redmond,  WA  98052
Applicant Contact Karen Hedine
Micronics, Inc
8464 154th Ave
Redmond,  WA  98052
Correspondent Contact Karen Hedine
Regulation Number866.3990
Classification Product Code
Subsequent Product Codes
Date Received10/23/2017
Decision Date 06/01/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No