Company · US
Diamond Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2020. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIT | Calibrator, Secondary | 9 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 6 |
| JGS | Electrode, Ion Specific, Sodium | 4 |
| CEM | Electrode, Ion Specific, Potassium | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2020 | K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ Diamond Diagnostics, Inc. | CEM |
| Aug 8, 2014 | K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS Diamond Diagnostics, Inc. | JIT |
| Apr 17, 2013 | K124009 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C Diamond Diagnostics, Inc. | JJY |
| Dec 20, 2012 | K121027 | DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH Diamond Diagnostics, Inc. | JIT |
| Aug 30, 2012 | K121040 | SMARTLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. | CEM |
| Aug 22, 2012 | K121140 | PROLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. | JGS |
| Apr 17, 2012 | K120591 | DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 Diamond Diagnostics, Inc. | JIT |
| May 6, 2011 | K103364 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL Diamond Diagnostics, Inc. | JJY |
| Jan 14, 2011 | K102959 | PROLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. | JGS |
| Jun 24, 2010 | K093357 | DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D Diamond Diagnostics, Inc. | JIT |
| Mar 19, 2010 | K093492 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR Diamond Diagnostics, Inc. | JJY |
| Mar 10, 2010 | K093384 | MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) Diamond Diagnostics, Inc. | JJY |
| Feb 6, 2009 | K082462 | GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ Diamond Diagnostics, Inc. | JGS |
| May 7, 2008 | K070104 | PROLYTE ELECTROLYTE ANALYZER Diamond Diagnostics, Inc. | JGS |
| Aug 8, 2007 | K071039 | MISSION OLYMPUS AU ISE CALIBRATORS Diamond Diagnostics, Inc. | JIT |
| Dec 1, 2006 | K062674 | MISSION TRINITY B Diamond Diagnostics, Inc. | JJY |
| Mar 21, 2006 | K060206 | MISSION COMPLETE Diamond Diagnostics, Inc. | JJY |
| Mar 4, 2004 | K033060 | CALIBRATING MATERIAL, CALIBRATING STANDARDS Diamond Diagnostics, Inc. | JIT |
| Jan 30, 2004 | K033058 | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS Diamond Diagnostics, Inc. | CGX |
| Jan 30, 2004 | K033056 | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT Diamond Diagnostics, Inc. | CDS |
| Jan 30, 2004 | K033055 | GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS Diamond Diagnostics, Inc. | CGA |
| Dec 12, 2003 | K033063 | MISSION CONTROLS Diamond Diagnostics, Inc. | JJS |
| Nov 7, 2003 | K033061 | CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE Diamond Diagnostics, Inc. | JIX |
| Jun 25, 2003 | K031159 | CALIBRATING MATERIAL, CALIBRATING STANDARDS Diamond Diagnostics, Inc. | JIT |
| Mar 23, 2002 | K020596 | CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS Diamond Diagnostics, Inc. | JIT |
| Dec 21, 2001 | K013850 | STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE Diamond Diagnostics, Inc. | JIT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||