FDA 510(k) Applications for Medical Device Product Code "QWH"

FDA 510(k) Number Applicant Device Name Decision Date
DEN220027 BRAHMS GmbH, Part of Thermo Fisher Scientific B╖R╖A╖H╖M╖S sFlt-1/ PlGF KRYPTOR Test System 05/18/2023
K241453 Roche Diagnostics Elecsys sFlt-1 and Elecsys PlGF 02/07/2025


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