Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K-Number: K153301 · 2016-04-08
ApplicantRoche Diagnostics
Decision Date2016-04-08
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2016-04-08 under approval number K153301. The device is classified under product code KXT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II?
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Roche Diagnostics. The 510(k) number is K153301.
When was Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II approved by the FDA?
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II received FDA 510(k) clearance on 2016-04-08, under approval number K153301.
What company makes Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II?
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II?
The FDA product code for Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II is KXT.
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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.