Alinity c Tricyclic Antidepressants Reagent Kit— 510(k) K231020

Substantially Equivalent

Microgenics Corporation

FDA 510(k) clearance K231020 for Alinity c Tricyclic Antidepressants Reagent Kit, Substantially Equivalent on 2023-11-17. Applicant: Microgenics Corporation. Device class: 2.

Clearance details

Applicant
Microgenics Corporation
Product code
Code LFH
Device class
Class 2
Regulation
21 CFR 862.3910
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fremont, CA, US
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