FDA 510(k) Applications for Medical Device Product Code: JIA (Enzymatic Methods, Galactose)

FDA 510(k) Applications for Medical Device Product Code "JIA"
(Enzymatic Methods, Galactose)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K121101	ASTORIA-PACIFIC,INC.	SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT	06/20/2013
K950481	ISOLAB, INC.	NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT	02/01/1996
K991498	NEOMETRICS, INC.	ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL	06/16/1999
K190335	PerkinElmer Inc.	GSP Neonatal Total Galactose kit	11/06/2019
K990644	QUANTASE LTD.	QUANTASE TOTAL GALACTOSE SCREENING ASSAY	06/21/1999
K990654	QUANTASE LTD.	QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT	06/21/1999
K071649	WALLAC OY	NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B	08/07/2008
K133652	WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.	GSP NEONATAL TOTAL GALACTOSE KIT	04/28/2014