Diamond Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K200544	SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+	CEM	2020-10-01	View
510(k)	K124009	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C	JJY	2013-04-17	View
510(k)	K121027	DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH	JIT	2012-12-20	View
510(k)	K121040	SMARTLYTE ELECTROLYTE ANALYZER	CEM	2012-08-30	View
510(k)	K121140	PROLYTE ELECTROLYTE ANALYZER	JGS	2012-08-22	View
510(k)	K120591	DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2	JIT	2012-04-17	View
510(k)	K103364	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL	JJY	2011-05-06	View
510(k)	K102959	PROLYTE ELECTROLYTE ANALYZER	JGS	2011-01-14	View
510(k)	K093357	DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D	JIT	2010-06-24	View
510(k)	K093492	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR	JJY	2010-03-19	View
510(k)	K093384	MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)	JJY	2010-03-10	View
510(k)	K082462	GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+	JGS	2009-02-06	View
510(k)	K070104	PROLYTE ELECTROLYTE ANALYZER	JGS	2008-05-07	View
510(k)	K071039	MISSION OLYMPUS AU ISE CALIBRATORS	JIT	2007-08-08	View
510(k)	K062674	MISSION TRINITY B	JJY	2006-12-01	View
510(k)	K060206	MISSION COMPLETE	JJY	2006-03-21	View
510(k)	K033060	CALIBRATING MATERIAL, CALIBRATING STANDARDS	JIT	2004-03-04	View
510(k)	K033058	CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS	CGX	2004-01-30	View
510(k)	K033056	BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT	CDS	2004-01-30	View
510(k)	K033055	GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS	CGA	2004-01-30	View