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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name U.V. Spectrometry, Tricyclic Antidepressant Drugs
510(k) Number K231020
Device Name Alinity c Tricyclic Antidepressants Reagent Kit
Applicant
Microgenics Corporation
45600 Kato Rd.
Fremont,  CA  94538
Applicant Contact Pranjali Shinde
Correspondent
Thermo Fisher Scientific
46500 Kato Rd.
Fremond,  CA  94538
Correspondent Contact Pranjali Shinde
Regulation Number862.3910
Classification Product Code
LFH  
Date Received04/10/2023
Decision Date 11/17/2023
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
Predetermined Change
Control Plan Authorized		 No
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