FDA 510(k) Application Details - K971221

Device Classification Name	Tubes, Vacuum Sample, With Anticoagulant   More FDA Info for this Device
510(K) Number	K971221
Device Name	Tubes, Vacuum Sample, With Anticoagulant
Applicant	GREINER AMERICA, INC. P.O. BOX 953279 LAKE MARY, FL 32795-3279 US Other 510(k) Applications for this Company
Contact	ED MAIER Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	GIM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/1997
Decision Date	05/02/1997
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