FDA 510(k) Application Details - K964452

Device Classification Name	Control, Hematocrit   More FDA Info for this Device
510(K) Number	K964452
Device Name	Control, Hematocrit
Applicant	RICHMOND DIAGNOSTICS, INC. 100 JERSEY AVE., SUITE 202A, BLDG. B NEW BRUNSWICK, NJ 08901 US Other 510(k) Applications for this Company
Contact	JOSEPH P PINENO Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GLK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/1996
Decision Date	02/20/1997
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