Diamond Diagnostics, Inc.
Medical device manufacturer in Holliston, MA.
26510(k) clearances
0PMA approvals
0recalls
Device types
- JIT Calibrator, Secondary 9
- JJY Multi-Analyte Controls, All Kinds (Assayed) 6
- JGS Electrode, Ion Specific, Sodium 4
- CEM Electrode, Ion Specific, Potassium 2
- JIX Calibrator, Multi-Analyte Mixture 1
- JJS Controls For Blood-Gases, (Assayed And… 1
- CGA Glucose Oxidase, Glucose 1
- CDS Electrode, Ion Specific, Urea Nitrogen 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEM · Traditional | 10/01/2020SE |
| K133751 | Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsJIT · Traditional | 08/08/2014SE |
| K124009 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed…JJY · Traditional | 04/17/2013SE |
| K121027 | Diamond Calibrator Low, Diamond Calibrator HighJIT · Traditional | 12/20/2012SE |
| K121040 | Smartlyte Electrolyte AnalyzerCEM · Traditional | 08/30/2012SE |
| K121140 | Prolyte Electrolyte AnalyzerJGS · Traditional | 08/22/2012SE |
| K120591 | Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2JIT · Traditional | 04/17/2012SE |
| K103364 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual LevelJJY · Traditional | 05/06/2011SE |
| K102959 | Prolyte Electrolyte AnalyzerJGS · Traditional | 01/14/2011SE |
| K093357 | Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module…JIT · Traditional | 06/24/2010SE |
| K093492 | Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical CalibratorJJY · Traditional | 03/19/2010SE |
| K093384 | Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)JJY · Traditional | 03/10/2010SE |
| K082462 | Gemlyte Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+JGS · Traditional | 02/06/2009SE |
| K070104 | Prolyte Electrolyte AnalyzerJGS · Traditional | 05/07/2008SE |
| K071039 | Mission Olympus Au Ise CalibratorsJIT · Traditional | 08/08/2007SE |
| K062674 | Mission Trinity BJJY · Traditional | 12/01/2006SE |
| K060206 | Mission CompleteJJY · Traditional | 03/21/2006SE |
| K033060 | Calibrating Material, Calibrating StandardsJIT · Traditional | 03/04/2004SE |
| K033058 | Creatinine Reagent Kit for Beckman Synchron CX & CX Delta SystemsCGX · Traditional | 01/30/2004SE |
| K033056 | Bun Reagent for Beckman Synchron CX & CX Delta ReagentCDS · Traditional | 01/30/2004SE |
| K033055 | Glucose Reagent for Beckman Synchron CX & CX Delta SystemsCGA · Traditional | 01/30/2004SE |
| K033063 | Mission ControlsJJS · Traditional | 12/12/2003SE |
| K033061 | Calibrating Material, Ise Electrolyte ReferenceJIX · Traditional | 11/07/2003SE |
| K031159 | Calibrating Material, Calibrating StandardsJIT · Traditional | 06/25/2003SE |
| K020596 | Calibrating Material,Cal-Pak, Cal & Slope StandardsJIT · Traditional | 03/23/2002SE |
| K013850 | Standard a, Standard B, Standard C, Cal, SlopeJIT · Traditional | 12/21/2001SE |