FDA 510(k) Application Details - K142821

Device Classification Name	More FDA Info for this Device
510(K) Number	K142821
Device Name	PAXgene Blood DNA Tube
Applicant	PREANALYTIX GMBH FELDBACHSTRASSE HOMBRECHTIKON 8634 CH Other 510(k) Applications for this Company
Contact	Pasquale Amato 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	09/30/2014
Decision Date	09/09/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review