FDA 510(k) Application Details - K992829

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K992829
Device Name	Plasma, Coagulation Control
Applicant	MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. CAMARILLO, CA 93012-8058 US Other 510(k) Applications for this Company
Contact	MARY D THORSNESS 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	08/23/1999
Decision Date	11/22/1999
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