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Data / Medical devices / Canada / Sensor Health Products, Inc.

Sensor Health Products, Inc.: FDA-registered device maker in CAMBRIDGE Ontario, Canada, 37 510(k) clearances

Sensor Health Products, Inc. is registered with the FDA (registration 3004192065) in CAMBRIDGE Ontario, Canada. It lists 53 device types. The FDA files 37 510(k) clearances under its listings, the newest dated May 10, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Sensor Health Products, Inc.
FDA registration number
3004192065
Address
6-110 Turnbull Court, CAMBRIDGE Ontario, Canada, N1T 1K6
Owner or operator
SENSOR HEALTH PRODUCTS, INC. (9072536)
Roles
Complaint file establishment, Exporter to the US, Repackager or relabeler
First device listed
April 26, 2005
Registered through
2026
Brand names listed
Beckman Coulter Inc, CONTAINER, SPECIMEN, NON-STERILE, Ethicon Inc, FORMALIN 10% NEUTRAL BUFFERED

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Folic, RadioimmunoassayCGN2Exporter to the USaccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Exporter to the USaccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Exporter to the USaccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Exporter to the USaccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Exporter to the USaccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Exporter to the USaccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Exporter to the USaccessdata.fda.gov
Calibrator, PrimaryJIS2Exporter to the USaccessdata.fda.gov
Calibrator, SecondaryJIT2Exporter to the USaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Complaint file establishmentaccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Exporter to the USaccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Exporter to the USaccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Exporter to the USaccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Exporter to the USaccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Exporter to the USaccessdata.fda.gov
Formalin, Neutral BufferedIFP1Repackager or relabeleraccessdata.fda.gov
General Purpose ReagentPPM1Complaint file establishmentaccessdata.fda.gov
Hexokinase, GlucoseCFR2Exporter to the USaccessdata.fda.gov
Immunochemical, Thyroglobulin AutoantibodyJNL2Exporter to the USaccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Exporter to the USaccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Exporter to the USaccessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlLBS1Exporter to the USaccessdata.fda.gov
Mercuric Thiocyanate, Colorimetry, ChlorideCHJ2Exporter to the USaccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Exporter to the USaccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Exporter to the USaccessdata.fda.gov
Radioassay, Vitamin B12CDD2Exporter to the USaccessdata.fda.gov
Radioimmunoassay (Two-Site Solid Phase), FerritinJMG2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Thyroxine-Binding GlobulinCEE2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Exporter to the USaccessdata.fda.gov
Refractometer For Clinical UseJRE1Exporter to the USaccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Exporter to the USaccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGAQ2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Exporter to the USaccessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)LTK2Exporter to the USaccessdata.fda.gov
Test, Natriuretic PeptideNBC2Exporter to the USaccessdata.fda.gov
Test, Urine LeukocyteLJX1Exporter to the USaccessdata.fda.gov
Tetrabromo-M-Cresolsulfonphthalein, AlbuminCJG2Exporter to the USaccessdata.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
May 10, 2024K240479Access OV MonitorLTKSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
August 18, 2016K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay SystemsJLWSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
June 30, 2014K141374BICARBONATE CALIBRATORJITSubstantially EquivalentBeckman Coulter Ireland, Inc.accessdata.fda.gov
December 6, 2013K133356PROLENE POLYPROPYLENE NONABSORBABLE SUTUREGAWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
October 1, 2013K130020ACCESS TOTAL BHCG (5TH IS)DHASubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
December 27, 2011K112933ACCESS THYROGLOBULIN ANITBODYJNLSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
May 13, 2011K110771BD SINGLE USE, HYPODERMIC SYRINGEFMFSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
April 21, 2006K060774FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208CGNSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
September 22, 2005K051787TRIAGE BNP TEST, MODEL 98000XRNBCSubstantially EquivalentBiosite Incorporatedaccessdata.fda.gov
August 19, 2005K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020JMGSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
March 10, 2004K040471OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024JITSubstantially EquivalentOlympus America, Inc.accessdata.fda.gov
September 13, 2002K022269COATED VICRYL* (POLYGLACTIN 910) SUTUREGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
March 1, 2001K010188BD ECLIPSE HYPODERMIC NEEDLEFMISubstantially EquivalentBd Medical Systemsaccessdata.fda.gov
August 22, 2000K001935ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565CDZSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
November 24, 1999K992257NEW MULTIPLES REAGENT STRIPSJIRSubstantially EquivalentBayer Corp.accessdata.fda.gov
July 14, 1998K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCECSubstantially EquivalentBeckman Instruments, Inc.accessdata.fda.gov
June 11, 1998K980987BECTON DICKINSON SYRINGEFMFSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
October 31, 1997K973966ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCDPSubstantially EquivalentBeckman Instruments, Inc.accessdata.fda.gov
September 9, 1997K972706CLINITEK MICROALBUMIN REAGENT STRIPSCJGSubstantially EquivalentBayer Corp.accessdata.fda.gov
February 25, 1997K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)CHPSubstantially EquivalentBio-Rad Laboratories, Inc.accessdata.fda.gov
March 29, 1996K960913ACCESS FREE T3 ASSAYCDPSubstantially EquivalentBio-Rad Laboratories, Inc.accessdata.fda.gov
February 5, 1996K955769ACCESS PROGESTERONE ASSAYJLSSubstantially EquivalentBio-Rad Laboratories, Inc.accessdata.fda.gov
January 24, 1996K955436ACCESS VITAMIN B12 ASSAY (MODIFICATION)CDDSubstantially EquivalentBio-Rad Laboratories, Inc.accessdata.fda.gov
October 20, 1995K954680ACCESS PROLACTIN ASSAY (MODIFICATION)CFTSubstantially EquivalentBio-Rad Laboratories, Inc.accessdata.fda.gov
January 9, 1995K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
March 3, 1994K940005ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAYCGJSubstantially EquivalentBio-Rad Laboratories, Inc.accessdata.fda.gov
September 21, 1993K931939OLYMPUS CREATININE REAGENTCGXSubstantially EquivalentOlympus Corp.accessdata.fda.gov
June 7, 1993K930010ACCESS THYROID UPTAKE ASSAYCEESubstantially EquivalentBio-Rad Laboratories, Inc.accessdata.fda.gov
February 8, 1993K925603OLYMPUS CHOLESTEROL REAGENTCHHSubstantially EquivalentOlympus Corp.accessdata.fda.gov
January 26, 1993K925337OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENTJQBSubstantially EquivalentOlympus Corp.accessdata.fda.gov
January 13, 1993K925802ACCESS DIGOXIN ASSAYKXTSubstantially EquivalentBio-Rad Laboratories, Inc.accessdata.fda.gov
December 29, 1992K924659OLYUMPUS TOTAL PROTEIN REAGENTCEKSubstantially EquivalentOlympus Corp.accessdata.fda.gov
December 18, 1992K924691OLYMPUS IRON REAGENTJIYSubstantially EquivalentOlympus Corp.accessdata.fda.gov
December 11, 1992K925338OLYMPUS CHLORIDE REAGENTCHJSubstantially EquivalentOlympus Corp.accessdata.fda.gov
December 3, 1992K924601OLYMPUS GLUCOSE REAGENTCFRSubstantially EquivalentOlympus Corp.accessdata.fda.gov
July 17, 1992K922369OLYMPUS ALBUMIN REAGENTCIXSubstantially EquivalentOlympus Corp.accessdata.fda.gov
July 16, 1992K922361OLYMPUS TOTAL PROTEIN REAGENTCEKSubstantially EquivalentOlympus Corp.accessdata.fda.gov

Compare with other makers

Updated May 10, 2024. 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.