FDA 510(k) Application Details - K120900

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K120900
Device Name	Plasma, Coagulation Control
Applicant	CLINIQA CORPORATION 288 DISTRIBUTION STREET SAN MARCOS, CA 92078 US Other 510(k) Applications for this Company
Contact	DAWN GAST Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2012
Decision Date	05/31/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review