FDA 510(k) Application Details - K192730

Device Classification Name	Titrimetric With Edta And Indicator, Calcium   More FDA Info for this Device
510(K) Number	K192730
Device Name	Titrimetric With Edta And Indicator, Calcium
Applicant	BioSystems S.A. Costa Brava, 30 Barcelona ES Other 510(k) Applications for this Company
Contact	Noelia Gil Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2019
Decision Date	09/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review