Medical Device Manufacturer · US , Holliston , MA

Diamond Diagnostics, Inc.

26 submissions · 26 cleared · Since 2001
26
Total
26
Cleared
0
Denied

Diamond Diagnostics, Inc. — FDA 510(k) Submissions

Diamond Diagnostics, Inc. has submitted 26 FDA 510(k) premarket notifications since 2001, of which 26 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrator, Secondary, Multi-analyte Controls, All Kinds (assayed), Electrode, Ion Specific, Sodium, Electrode, Ion Specific, Potassium, Glucose Oxidase, Glucose . Use the specialty filter in the sidebar to narrow results.

26 devices
1–25 of 26
SmartLyte? Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
K200544 · CEM Electrode, Ion Specific,... · Chemistry
Oct 2020 212d
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
K133751 · JIT Calibrator, Secondary · Chemistry
Aug 2014 242d
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
K124009 · JJY Multi-analyte Controls,... · Chemistry
Apr 2013 111d
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
K121027 · JIT Calibrator, Secondary · Chemistry
Dec 2012 260d
SMARTLYTE ELECTROLYTE ANALYZER
K121040 · CEM Electrode, Ion Specific,... · Chemistry
Aug 2012 147d
PROLYTE ELECTROLYTE ANALYZER
K121140 · JGS Electrode, Ion Specific,... · Chemistry
Aug 2012 128d
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
K120591 · JIT Calibrator, Secondary · Chemistry
Apr 2012 49d
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
K103364 · JJY Multi-analyte Controls,... · Chemistry
May 2011 171d
PROLYTE ELECTROLYTE ANALYZER
K102959 · JGS Electrode, Ion Specific,... · Chemistry
Jan 2011 101d
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
K093357 · JIT Calibrator, Secondary · Chemistry
Jun 2010 239d
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR
K093492 · JJY Multi-analyte Controls,... · Chemistry
Mar 2010 129d
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
K093384 · JJY Multi-analyte Controls,... · Chemistry
Mar 2010 131d
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
K082462 · JGS Electrode, Ion Specific,... · Chemistry
Feb 2009 163d
PROLYTE ELECTROLYTE ANALYZER
K070104 · JGS Electrode, Ion Specific,... · Chemistry
May 2008 483d
MISSION OLYMPUS AU ISE CALIBRATORS
K071039 · JIT Calibrator, Secondary · Chemistry
Aug 2007 118d
MISSION TRINITY B
K062674 · JJY Multi-analyte Controls,... · Chemistry
Dec 2006 84d
MISSION COMPLETE
K060206 · JJY Multi-analyte Controls,... · Chemistry
Mar 2006 54d
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K033060 · JIT Calibrator, Secondary · Chemistry
Mar 2004 157d
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033055 · CGA Glucose Oxidase, Glucose · Chemistry
Jan 2004 123d
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
K033056 · CDS Electrode, Ion Specific,... · Chemistry
Jan 2004 123d
CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033058 · CGX Alkaline Picrate,... · Chemistry
Jan 2004 123d
MISSION CONTROLS
K033063 · JJS Controls For Blood-gases,... · Chemistry
Dec 2003 74d
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
K033061 · JIX Calibrator, Multi-analyte... · Chemistry
Nov 2003 39d
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K031159 · JIT Calibrator, Secondary · Chemistry
Jun 2003 72d
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
K020596 · JIT Calibrator, Secondary · Chemistry
Mar 2002 29d
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