FDA 510(k) Application Details - K042927

Device Classification Name	More FDA Info for this Device
510(K) Number	K042927
Device Name	VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
Applicant	GREINER BIO-ONE VACUETTE NORTH AMERICA PO BOX 103 BALDWIN, MD 21013 US Other 510(k) Applications for this Company
Contact	Judi Smith 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	10/22/2004
Decision Date	04/15/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review