FDA 510(k) Application Details - K964698

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K964698
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	ANDWIN SCIENTIFIC 1219 EAST BRIDLETRAIL RD. DRAPER, UT 84020-8523 US Other 510(k) Applications for this Company
Contact	A. THOMAS DOYLE 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	11/22/1996
Decision Date	03/03/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review