UBI universal biosensors inc.

FDA 510(k) approval

  1. 665 Posts.
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    For those who are interested, the FDA pre-market 510(k) approvals for the previous week are posted online each Tuesday morning, Australian time. Have been checking this each week for a long time, and was pleasantly surprised to see that Xprecia Stride appears to have received a decision of "Substantially Equivalent (SESE)". Seehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151964
    [Sorry - didn't post to UBI symbol, first time]
 
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