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Data / Medical devices / United States / DIAMOND DIAGNOSTICS Inc

DIAMOND DIAGNOSTICS Inc: FDA-registered device maker in Holliston, MA, United States, 28 510(k) clearances

DIAMOND DIAGNOSTICS Inc is registered with the FDA (registration 3003030793) in Holliston, MA, United States. It lists 33 device types. The FDA files 28 510(k) clearances under its listings, the newest dated October 1, 2020. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch DIAMOND DIAGNOSTICS Inc
FDA registration number
3003030793
Address
333 Fiske St, Holliston, MA, United States, 01746
Owner or operator
Diamond Diagnostics Inc. (10028706)
Roles
Contract manufacturer, Manufacturer
First device listed
February 26, 2009
Registered through
2026
Brand names listed
Analyzer, Automated Test System, BK BUN, BK Creatinine, BK Glucose, BK ISE, CALIBRATOR, CD Cal-Packs and more

Devices it lists

DeviceProduct codeClassRoleSource
Alkaline Picrate, Colorimetry, CreatinineCGX2Manufactureraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Contract manufacturer, Manufactureraccessdata.fda.gov
Bordetella Pertussis Dna Assay SystemOZZ2Contract manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufactureraccessdata.fda.gov
Calibrator, SecondaryJIT2Manufactureraccessdata.fda.gov
Controls For Blood-Gases, (Assayed And Unassayed)JJS1Manufactureraccessdata.fda.gov
Electrode, Ion Specific, CalciumJFP2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, Urea NitrogenCDS2Manufactureraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Contract manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RubellaLFX2Contract manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD2Contract manufactureraccessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDAP2Contract manufactureraccessdata.fda.gov
Flame Photometry, LithiumJIH2Manufactureraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Manufactureraccessdata.fda.gov
Helicobacter PyloriLYR1Contract manufactureraccessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay SystemOEM2Contract manufactureraccessdata.fda.gov
Influenza A Virus Subtype Differentiation Nucleic Acid AssayOEP2Contract manufactureraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Manufactureraccessdata.fda.gov
Mycoplasma Pneumoniae Dna Assay SystemOZX2Contract manufactureraccessdata.fda.gov
Non-Sars Coronavirus Multiplex Nucleic Acid AssayOTG2Contract manufactureraccessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid AssayOOU2Contract manufactureraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Contract manufactureraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Contract manufactureraccessdata.fda.gov
Reagent, Borrelia Serological ReagentLSR2Contract manufactureraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Contract manufactureraccessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay SystemOCC2Contract manufactureraccessdata.fda.gov
System, Blood CulturingMDB1Contract manufactureraccessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenNQX2Contract manufactureraccessdata.fda.gov
System, Test, Automated, Antimicrobial Susceptibility, Short IncubationLON2Contract manufactureraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 1, 2020K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEMSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
August 8, 2014K133751DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDSJITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
April 17, 2013K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION CJJYSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
December 20, 2012K121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHJITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
August 30, 2012K121040SMARTLYTE ELECTROLYTE ANALYZERCEMSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
August 22, 2012K121140PROLYTE ELECTROLYTE ANALYZERJGSSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
April 17, 2012K120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2JITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
May 6, 2011K103364MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVELJJYSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
January 14, 2011K102959PROLYTE ELECTROLYTE ANALYZERJGSSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
June 24, 2010K093357DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410DJITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
March 19, 2010K093492MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATORJJYSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
March 10, 2010K093384MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)JJYSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
February 6, 2009K082462GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+JGSSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
May 7, 2008K070104PROLYTE ELECTROLYTE ANALYZERJGSSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
August 8, 2007K071039MISSION OLYMPUS AU ISE CALIBRATORSJITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
December 1, 2006K062674MISSION TRINITY BJJYSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
March 21, 2006K060206MISSION COMPLETEJJYSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
March 4, 2004K033060CALIBRATING MATERIAL, CALIBRATING STANDARDSJITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
January 30, 2004K033058CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMSCGXSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
January 30, 2004K033056BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENTCDSSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
January 30, 2004K033055GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMSCGASubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
December 12, 2003K033063MISSION CONTROLSJJSSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
November 7, 2003K033061CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCEJIXSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
June 25, 2003K031159CALIBRATING MATERIAL, CALIBRATING STANDARDSJITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
July 22, 2002K022027CALIBRATING MATERIAL, BUFFERS, STANDARDJITSubstantially EquivalentMission Diagnosticsaccessdata.fda.gov
April 29, 2002K020894CALIBRATING MATERIAL, CAL-PAK, BUFFERSJITSubstantially EquivalentMission Diagnosticsaccessdata.fda.gov
March 23, 2002K020596CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDSJITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov
December 21, 2001K013850STANDARD A, STANDARD B, STANDARD C, CAL, SLOPEJITSubstantially EquivalentDiamond Diagnostics, Inc.accessdata.fda.gov

Compare with other makers

Updated October 1, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.