FDA 510(k) Application Details - K984141

Device Classification Name	Activated Whole Blood Clotting Time   More FDA Info for this Device
510(K) Number	K984141
Device Name	Activated Whole Blood Clotting Time
Applicant	SIENCO, INC. 4892 VAN GORDON ST., UNIT 203 WHEATRIDGE, 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	11/18/1998
Decision Date	05/28/1999
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