FDA 510(k) Application Details - K991362

Device Classification Name	System, Analysis, Electrophoretic Hemoglobin   More FDA Info for this Device
510(K) Number	K991362
Device Name	System, Analysis, Electrophoretic Hemoglobin
Applicant	MORAX 13805 WATERLOO RD. CHELSEA, MI 48118 US Other 510(k) Applications for this Company
Contact	BOREK JANIK Other 510(k) Applications for this Contact
Regulation Number	864.7440   More FDA Info for this Regulation Number
Classification Product Code	JBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/1999
Decision Date	06/21/1999
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