FDA 510(k) Applications for Medical Device Product Code: KHG (Whole Blood Hemoglobin Determination)

FDA 510(k) Applications for Medical Device Product Code "KHG"
(Whole Blood Hemoglobin Determination)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K042379	BIOSAFE LABORATORIES, INC.	ANEMIAPRO SELF-SCREENER	12/15/2004
K001462	CARESIDE, INC.	CARESIDE HEMOGLOBIN	08/21/2000
K020138	GDS TECHNOLOGY	STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090	02/11/2002
K973649	GDS TECHNOLOGY, LLC.	HEMOSITE TEST SYSTEM	08/31/1998
K994073	GDS TECHNOLOGY, LLC.	HEMOSITE TEST SYSTEM	01/14/2000
K221508	Sanguina, Inc.	AnemoCheck Home	09/29/2023
K163215	SANGUINA, LLC	AnemoCheck	09/13/2017