DRI TM Tricyclics Serum Tox Assay
K-Number: K213875 · 2022-12-21
ApplicantMicrogenics Corporation
Decision Date2022-12-21
Product CodeLFH
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
DRI TM Tricyclics Serum Tox Assay is a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2022-12-21 under approval number K213875. 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 DRI TM Tricyclics Serum Tox Assay?
DRI TM Tricyclics Serum Tox Assay is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Microgenics Corporation. The 510(k) number is K213875.
When was DRI TM Tricyclics Serum Tox Assay approved by the FDA?
DRI TM Tricyclics Serum Tox Assay received FDA 510(k) clearance on 2022-12-21, under approval number K213875.
What company makes DRI TM Tricyclics Serum Tox Assay?
DRI TM Tricyclics Serum Tox Assay is manufactured by Microgenics Corporation.
What is the FDA product code for DRI TM Tricyclics Serum Tox Assay?
The FDA product code for DRI TM Tricyclics Serum Tox Assay 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.