FDA 510(k) Application Details - K955719

Device Classification Name	Hemoglobin S   More FDA Info for this Device
510(K) Number	K955719
Device Name	Hemoglobin S
Applicant	MEDICUS TECHNOLOGIES, INC. 515 SOUTH FRANKLIN ST. WEST CHESTER, PA 19382 US Other 510(k) Applications for this Company
Contact	JOHN F O'DONNELL Other 510(k) Applications for this Contact
Regulation Number	864.7415   More FDA Info for this Regulation Number
Classification Product Code	GIQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/1995
Decision Date	08/14/1996
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