FDA 510(k) Application Details - K973649

Device Classification Name	Whole Blood Hemoglobin Determination   More FDA Info for this Device
510(K) Number	K973649
Device Name	Whole Blood Hemoglobin Determination
Applicant	GDS TECHNOLOGY, LLC. 25235 LEER DR. ELKHART, IN 46514 US Other 510(k) Applications for this Company
Contact	JONATHAN A KOVACH 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	09/25/1997
Decision Date	08/31/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review