DIAMOND DIAGNOSTICS Inc
Holliston, MA, US
DIAMOND DIAGNOSTICS Inc appears in FDA device records in Holliston, MA. FDA records list 26 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for DIAMOND DIAGNOSTICS Inc between 2001 and 2020. The busiest year on record is 2004, with 4. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 4 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | CEM | Substantially Equivalent | |
| K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | JIT | Substantially Equivalent | |
| K124009 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C | JJY | Substantially Equivalent | |
| K121027 | DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH | JIT | Substantially Equivalent | |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | CEM | Substantially Equivalent | |
| K121140 | PROLYTE ELECTROLYTE ANALYZER | JGS | Substantially Equivalent | |
| K120591 | DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 | JIT | Substantially Equivalent | |
| K103364 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL | JJY | Substantially Equivalent | |
| K102959 | PROLYTE ELECTROLYTE ANALYZER | JGS | Substantially Equivalent | |
| K093357 | DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D | JIT | Substantially Equivalent | |
| K093492 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR | JJY | Substantially Equivalent | |
| K093384 | MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) | JJY | Substantially Equivalent | |
| K082462 | GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ | JGS | Substantially Equivalent | |
| K070104 | PROLYTE ELECTROLYTE ANALYZER | JGS | Substantially Equivalent | |
| K071039 | MISSION OLYMPUS AU ISE CALIBRATORS | JIT | Substantially Equivalent | |
| K062674 | MISSION TRINITY B | JJY | Substantially Equivalent | |
| K060206 | MISSION COMPLETE | JJY | Substantially Equivalent | |
| K033060 | CALIBRATING MATERIAL, CALIBRATING STANDARDS | JIT | Substantially Equivalent | |
| K033058 | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | CGX | Substantially Equivalent | |
| K033056 | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT | CDS | Substantially Equivalent | |
| K033055 | GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | CGA | Substantially Equivalent | |
| K033063 | MISSION CONTROLS | JJS | Substantially Equivalent | |
| K033061 | CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE | JIX | Substantially Equivalent | |
| K031159 | CALIBRATING MATERIAL, CALIBRATING STANDARDS | JIT | Substantially Equivalent | |
| K020596 | CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS | JIT | Substantially Equivalent | |
| K013850 | STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE | JIT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003030793 | 3003030793 | DIAMOND DIAGNOSTICS Inc | 333 Fiske St, Holliston, MA 01746 US | 2026 | and 23 more, listed in full below |
| 3006198300 | 3006198300 | Diamond Diagnostics Inc. | 6 Oradna Street, Budapest 1044 HU | 2026 | and 231 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CJXAcid Phosphatase, Disodium Phenylphosphate
- CKBAcid Phosphatase, Naphthyl Phosphate
- CGNAcid, Folic, Radioimmunoassay
- CDOAcid, Uric, Uricase (U.V.)
- DCFAlbumin, Antigen, Antiserum, Control
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CGLElectrode, Ion Based, Enzymatic, Creatinine
- CEMElectrode, Ion Specific, Potassium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DBFFerritin, Antigen, Antiserum, Control
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- CGAGlucose Oxidase, Glucose
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CZPIga, Antigen, Antiserum, Control
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control
- CHNImmunochemical, Ceruloplasmin
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- CDDRadioassay, Vitamin B12
- CKGRadioimmunoassay, Acth
- CGRRadioimmunoassay, Cortisol
- CGTRadioimmunoassay, Cyclic Gmp
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFLRadioimmunoassay, Human Growth Hormone
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDPRadioimmunoassay, Total Triiodothyronine
- DCNSystem, Test, C-Reactive Protein
- DDGTransferrin, Antigen, Antiserum, Control
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain