FDA 510(k) Applications for Medical Device Product Code: KHP (Acid, Lactic, Enzymatic Method)

FDA 510(k) Applications for Medical Device Product Code "KHP"
(Acid, Lactic, Enzymatic Method)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K130113	ABAXIS, INC.	PICCOLO LACTATE TEST SYSTEM	03/11/2013
K112430	ABBOTT PONT OF CARE INC	I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE	12/20/2011
K013938	DIAMETRICS MEDICAL, INC.	IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE	01/28/2002
K093297	EPOCAL, INC.	EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE	06/09/2010
K982071	I-STAT CORP.	I-STAT LACTATE TEST	06/29/1998
K011478	I-STAT CORP.	I-STAT SYSTEM	07/02/2001
K971944	JWT, INC.	LACTEST I	12/17/1997
K980908	KDK CORP.	LACTATE PRO SYSTEM	09/11/1998
K100602	NOVA BIOMEDICAL CORP.	NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS	08/17/2011
K112955	NOVA BIOMEDICAL CORPORATION	NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM	01/05/2012
K113216	SIEMENS HEALTHCARE DIAGNOSTICS	RAPIDPOINT 500 BLOOD GAS ANALYER	05/03/2012