FDA 510(k) Application Details - K961054

Device Classification Name	Counter, Urine Particle   More FDA Info for this Device
510(K) Number	K961054
Device Name	Counter, Urine Particle
Applicant	SYSMEX CORP. GILMER RD. 6699 RFD LONG GROVE, IL 60047-9596 US Other 510(k) Applications for this Company
Contact	NINA GAMPERLING Other 510(k) Applications for this Contact
Regulation Number	864.5200   More FDA Info for this Regulation Number
Classification Product Code	LKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/1996
Decision Date	10/28/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review