Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K-Number: K162678 · 2017-06-23
ApplicantRoche Diagnostics
Decision Date2017-06-23
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2017-06-23 under approval number K162678. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is a medical device that received FDA 510(k) clearance on 2017-06-23. It is manufactured by Roche Diagnostics. The 510(k) number is K162678.
When was Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl approved by the FDA?
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl received FDA 510(k) clearance on 2017-06-23, under approval number K162678.
What company makes Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?
The FDA product code for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is LGD.
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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.