FDA 510(k) Application Details - K042379

Device Classification Name	Whole Blood Hemoglobin Determination   More FDA Info for this Device
510(K) Number	K042379
Device Name	Whole Blood Hemoglobin Determination
Applicant	BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 LAKE FOREST, IL 60045 US Other 510(k) Applications for this Company
Contact	JACK A MAGGIORE Other 510(k) Applications for this Contact
Regulation Number	864.7500   More FDA Info for this Regulation Number
Classification Product Code	KHG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2004
Decision Date	12/15/2004
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