FDA 510(k) Application Details - K936240

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K936240
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	SUDORMED, INC. 12341 NEWPORT AVE., #D-200 SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	JON BOOHER, PH.D 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	12/30/1993
Decision Date	03/19/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review