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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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