FDA 510(k) Application Details - K984130

Device Classification Name	Control, Plasma, Abnormal   More FDA Info for this Device
510(K) Number	K984130
Device Name	Control, Plasma, Abnormal
Applicant	PACIFIC HEMOSTASIS 11515 VANSTORY DR. HUNTERSVILLE, NC 28078-8144 US Other 510(k) Applications for this Company
Contact	MARK ELLIS Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1998
Decision Date	12/01/1998
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