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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system
510(k) Number K183530
Device Name TruDiagnosis System
Akonni Biosystems Inc.
400 Sagner Ave, Suite 300
Frederick,  MD  21701
Applicant Contact Charles Daitch
MethodSense, Inc.
1 Copley Parkway, Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number862.3360
Classification Product Code
Subsequent Product Codes
Date Received12/19/2018
Decision Date 05/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No