IDL Biotech
IDL Biotech: 510k path confirmed (Redeye)

2019-10-07 08:05
On Friday, IDL Biotech announced that it have recieved feedback from the FDA regarding its pre-submission request. It is now confimed IDL will pursue the 510k route in order to reach approval for UBC Rapid in the US market. We have a positive view on the news, as IDL has to show that UBC Rapid is "substantially equivalent" to a predicate device already approved by the FDA (most probably NMP22).

info@redeye.se (Redeye.se)
Redeye AB - Redeye.se

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