FDA 510(k) Application Details - K954437

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K954437
Device Name	Instrument, Coagulation, Automated
Applicant	HAEMOSCOPE CORP. 7855 GROSS POINT RD. SUITE G4 SKOKIE, IL 60077 US Other 510(k) Applications for this Company
Contact	CHARMAINE SUTTON Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	GKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/1995
Decision Date	01/30/1996
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