FDA 510(k) Application Details - K960005

Device Classification Name	Mixture, Hematology Quality Control   More FDA Info for this Device
510(K) Number	K960005
Device Name	Mixture, Hematology Quality Control
Applicant	HEMATRONIX, INC. 524 STONE RD. SUITE A BENICIA, CA 94510 US Other 510(k) Applications for this Company
Contact	DEBBY BERCE Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	JPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/1996
Decision Date	03/19/1996
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