FDA 510(k) Application Details - K994073

Device Classification Name	Whole Blood Hemoglobin Determination   More FDA Info for this Device
510(K) Number	K994073
Device Name	Whole Blood Hemoglobin Determination
Applicant	GDS TECHNOLOGY, LLC. 25235 LEER DR. P.O. BOX 473 ELKHART, IN 46515 US Other 510(k) Applications for this Company
Contact	KEITH CRAWFORD 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	12/02/1999
Decision Date	01/14/2000
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