Alinity c Tricyclic Antidepressants Reagent Kit
K-Number: K231020 · 2023-11-17
ApplicantMicrogenics Corporation
Decision Date2023-11-17
Product CodeLFH
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
Alinity c Tricyclic Antidepressants Reagent Kit is a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2023-11-17 under approval number K231020. The device is classified under product code LFH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alinity c Tricyclic Antidepressants Reagent Kit?
Alinity c Tricyclic Antidepressants Reagent Kit is a medical device that received FDA 510(k) clearance on 2023-11-17. It is manufactured by Microgenics Corporation. The 510(k) number is K231020.
When was Alinity c Tricyclic Antidepressants Reagent Kit approved by the FDA?
Alinity c Tricyclic Antidepressants Reagent Kit received FDA 510(k) clearance on 2023-11-17, under approval number K231020.
What company makes Alinity c Tricyclic Antidepressants Reagent Kit?
Alinity c Tricyclic Antidepressants Reagent Kit is manufactured by Microgenics Corporation.
What is the FDA product code for Alinity c Tricyclic Antidepressants Reagent Kit?
The FDA product code for Alinity c Tricyclic Antidepressants Reagent Kit is LFH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.