FDA 510(k) Application Details - K020138

Device Classification Name	Whole Blood Hemoglobin Determination   More FDA Info for this Device
510(K) Number	K020138
Device Name	Whole Blood Hemoglobin Determination
Applicant	GDS TECHNOLOGY 25235 LEER DR. ELKHART, IN 46514 US Other 510(k) Applications for this Company
Contact	RICHARD TYHACH 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	01/16/2002
Decision Date	02/11/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review