FDA 510(k) Application Details - K231469

Device Classification Name	More FDA Info for this Device
510(K) Number	K231469
Device Name	PAXgene« Blood DNA Tube
Applicant	PreAnalytiX GmbH Garstligweg 8 Hombrechtikon 8634 CH Other 510(k) Applications for this Company
Contact	Alexandra Kirby Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2023
Decision Date	06/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review