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Diamond Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
6
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+October 1, 2020
K133751DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDSAugust 8, 2014
K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLApril 17, 2013
K121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHDecember 20, 2012
K121040SMARTLYTE ELECTROLYTE ANALYZERAugust 30, 2012
K121140PROLYTE ELECTROLYTE ANALYZERAugust 22, 2012
K120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2April 17, 2012
K103364MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVELMay 6, 2011
K102959PROLYTE ELECTROLYTE ANALYZERJanuary 14, 2011
K093357DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL MJune 24, 2010
K093492MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATORMarch 19, 2010
K093384MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)March 10, 2010
K082462GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+February 6, 2009
K070104PROLYTE ELECTROLYTE ANALYZERMay 7, 2008
K071039MISSION OLYMPUS AU ISE CALIBRATORSAugust 8, 2007
K062674MISSION TRINITY BDecember 1, 2006
K060206MISSION COMPLETEMarch 21, 2006
K033060CALIBRATING MATERIAL, CALIBRATING STANDARDSMarch 4, 2004
K033058CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMSJanuary 30, 2004
K033055GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMSJanuary 30, 2004