FDA 510(k) Application Details - K122687

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K122687
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	GREINER BIO-ONE NORTH AMERICA, INC. P.O. 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	862.1675   More FDA Info for this Regulation Number
Classification Product Code	JKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2012
Decision Date	01/10/2013
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