FDA 510(k) Applications for Medical Device Product Code: JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))

FDA 510(k) Applications for Medical Device Product Code "JIR"
(Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K983774	ABBOTT LABORATORIES	UALB	01/28/1999
K150330	ACON Laboratories, Inc.	Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)	04/30/2015
K970932	AMERICAN LABORATORY PRODUCTS CO., LTD.	ORGENTEC MICRO-ALBUMIN EIA ASSAY	04/08/1997
K963142	BAYER CORP.	DCA 2000 + MICROALBUMIN/CREATININE ASSAY	09/27/1996
K982219	BAYER CORP.	MICROALBUSTIX REAGENT STRIPS	08/12/1998
K991315	BAYER CORP.	MICROALBUSTIX REAGENT STRIPS (OTC)	11/12/1999
K992257	BAYER CORP.	NEW MULTIPLES REAGENT STRIPS	11/24/1999
K972337	DIAGNOSTIC CHEMICALS LTD.	DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA	08/08/1997
K994035	DIAGNOSTIC CHEMICALS LTD.	IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15	02/01/2000
K022538	DIAGNOSTIC CHEMICALS, LTD. (USA)	IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25	08/23/2002
K001810	FLEXSITE DIAGNOSTICS, INC.	URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING	08/14/2000
K210069	Healthy.io Ltd.	Minuteful - kidney test	07/06/2022
K222921	Healthy.io Ltd.	Minuteful-kidney test	09/08/2023
K960274	ORGENTEC	ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY	03/29/1996
K951222	RANDOX LABORATORIES, LTD.	TOTAL PROTEIN (URINE)	04/24/1996
K972960	TCPI, INC.	HEALTH CHECK URI-TEST PROTEIN IN URINE	10/07/1998
K061419	TECO DIAGNOSTICS	TECO MICROALBUMIN 2-1 COMBO STRIPS	01/26/2007
K955438	TECO DIAGNOSTICS	URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)	01/29/1996