FDA 510(k) Application Details - K040146

Device Classification Name	Abnormal Hemoglobin Quantitation   More FDA Info for this Device
510(K) Number	K040146
Device Name	Abnormal Hemoglobin Quantitation
Applicant	INTERLAB S.R.L. 150 CHERRY LANE RD. EAST STROUDSBURG, PA 18301-8804 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	864.7415   More FDA Info for this Regulation Number
Classification Product Code	GKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2004
Decision Date	05/04/2004
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