Elecsys Tacrolimus
K-Number: K173857 · 2018-11-06
ApplicantRoche Diagnostics
Decision Date2018-11-06
Product CodeMLM
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Elecsys Tacrolimus is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2018-11-06 under approval number K173857. 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 Elecsys Tacrolimus?
Elecsys Tacrolimus is a medical device that received FDA 510(k) clearance on 2018-11-06. It is manufactured by Roche Diagnostics. The 510(k) number is K173857.
When was Elecsys Tacrolimus approved by the FDA?
Elecsys Tacrolimus received FDA 510(k) clearance on 2018-11-06, under approval number K173857.
What company makes Elecsys Tacrolimus?
Elecsys Tacrolimus is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Tacrolimus?
The FDA product code for Elecsys Tacrolimus is MLM.
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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.