FDA 510(k) Application Details - K050821

Device Classification Name	Instrument, Coagulation   More FDA Info for this Device
510(K) Number	K050821
Device Name	Instrument, Coagulation
Applicant	ZYCARE 3804 SWEETEN CREEK RD. CHAPEL HILL, NC 27514 US Other 510(k) Applications for this Company
Contact	STEVE D HOLDAWAY Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	KQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2005
Decision Date	08/16/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review