FDA 510(k) Application Details - K963908

Device Classification Name	Control, Hemoglobin   More FDA Info for this Device
510(K) Number	K963908
Device Name	Control, Hemoglobin
Applicant	DIRECT SOLUTIONS 7 HAYRICK LN. P.O. BOX 900 WESTFORD, MA 01886 US Other 510(k) Applications for this Company
Contact	BILL DONOHUE Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/1996
Decision Date	10/16/1996
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