FDA 510(k) Application Details - K002528

Device Classification Name	Activated Whole Blood Clotting Time   More FDA Info for this Device
510(K) Number	K002528
Device Name	Activated Whole Blood Clotting Time
Applicant	SIENCO, INC. 11485-A WEST 48TH AVE. WHEAT RIDGE, CO 80033 US Other 510(k) Applications for this Company
Contact	BARBARA DEBIASE Other 510(k) Applications for this Contact
Regulation Number	864.7140   More FDA Info for this Regulation Number
Classification Product Code	JBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2000
Decision Date	08/31/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review