FDA 510(k) Application Details - DEN220027

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220027
Device Name	B╖R╖A╖H╖M╖S sFlt-1/ PlGF KRYPTOR Test System
Applicant	BRAHMS GmbH, Part of Thermo Fisher Scientific Neuensdorfstrasse 25 Hennigsdorf 16761 DE Other 510(k) Applications for this Company
Contact	Anja Jagalla Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2022
Decision Date	05/18/2023
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review