Tacrolimus Assay Kit
K-Number: K203833 · 2023-01-27
Decision Date2023-01-27
Product CodeMLM
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Tacrolimus Assay Kit is a medical device manufactured by Shanghai Genext Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-27 under approval number K203833. The device is classified under product code MLM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tacrolimus Assay Kit?
Tacrolimus Assay Kit is a medical device that received FDA 510(k) clearance on 2023-01-27. It is manufactured by Shanghai Genext Medical Technology Co., Ltd.. The 510(k) number is K203833.
When was Tacrolimus Assay Kit approved by the FDA?
Tacrolimus Assay Kit received FDA 510(k) clearance on 2023-01-27, under approval number K203833.
What company makes Tacrolimus Assay Kit?
Tacrolimus Assay Kit is manufactured by Shanghai Genext Medical Technology Co., Ltd..
What is the FDA product code for Tacrolimus Assay Kit?
The FDA product code for Tacrolimus Assay Kit is MLM.
Related Devices (Code: MLM)
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.