Reuters logo
BRIEF-Biocartis' Idylla Instrument and Idylla Console exempt from FDA 510(k) notification requirements
July 12, 2017 / 5:05 AM / 5 months ago

BRIEF-Biocartis' Idylla Instrument and Idylla Console exempt from FDA 510(k) notification requirements

July 12 (Reuters) - BIOCARTIS GROUP NV:

* REG-BIOCARTIS GROUP NV: BIOCARTIS’ IDYLLA(TM) INSTRUMENT AND IDYLLA(TM) CONSOLE EXEMPT FROM US FDA 510(K) NOTIFICATION REQUIREMENTS

* ‍ALL OTHER US 510(K) REQUIREMENTS REMAIN IN EFFECT​

* ‍CAN NOW WITHDRAW PENDING 510(K) SUBMISSION FOR IDYLLA(TM) INSTRUMENT AND IDYLLA(TM) CONSOLE​

* BIOCARTIS - ‍EXEMPTION DOES NOT CHANGE ONGOING UNDERTAKING OF BIOCARTIS AND JANSSEN DIAGNOSTICS TO OBTAIN 510(K) CLEARANCE FOR JANSSEN IDYLLA RESPIRATORY (IFV-RSV) PANEL TEST​ Source text for Eikon: Further company coverage: (Gdynia Newsroom)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below