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Data / Medical devices / United States / Scientific Supplies & Technology, Inc.

Scientific Supplies & Technology, Inc.: FDA-registered device maker in Doral, FL, United States, 16 510(k) clearances

Scientific Supplies & Technology, Inc. is registered with the FDA (registration 1036362) in Doral, FL, United States. It lists 89 device types. The FDA files 16 510(k) clearances under its listings, the newest dated September 1, 2016. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
1036362
Address
7245 N.W. 43RD ST., Doral, FL, United States, 33166
Owner or operator
SST International Inc. (1036362)
Roles
Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer
First device listed
June 19, 2018
Registered through
2027
Brand names listed
ACT 5 DIFF, ACT 5 DIFF AL, Bio-Chem, Clinitek Analyzer, EON Analyzer, EXCELSIOR AS TISSUE PROCESSOR, Easylyte Analyzer, Envoy Analyzer and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid Phosphatase (Prostatic), Tartrate InhibitedJFH2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Acid, Folic, RadioimmunoassayCGN2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Albumin, Rhodamine, Antigen, Antiserum, ControlDFJ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Automated Urinalysis SystemKQO1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Calibrator, SecondaryJIT2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Column Chromatography & Color Development, HydroxyprolineJMM1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Counter, Differential CellGKZ2Remanufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhCHL2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, CarbamazepineKLT2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, DigitoxinLFM2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, DiphenylhydantoinDIP2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, TheophyllineKLS2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Valproic AcidLEG2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, CytomegalovirusLFZ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificLGC2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RubellaLFX2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Flame Photometry, LithiumJIH2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Fluorometric Method, Cpk Or IsoenzymesJHX2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Helicobacter PyloriLYR1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Ige, Peroxidase, Antigen, Antiserum, ControlDGO2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular CancerLOJ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Processor, Tissue, AutomatedIEO1Specification developeraccessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate CancersLTJ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioassay, Vitamin B12CDD2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay (Two-Site Solid Phase), FerritinJMG2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, ActhCKG2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, CortisolCGR2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Cyclic GmpCGT2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstriolCGI1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Human Growth HormoneCFL1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Human Placental LactogenJMF2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Immunoglobulins (D, E)JHR2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Parathyroid HormoneCEW2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Thyroxine-Binding GlobulinCEE2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Refractometer For Clinical UseJRE1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Sterilizer, SteamFLE2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Carcinoembryonic AntigenDHX2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Immunological, Antigen, TumorMOI2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Radioallergosorbent (Rast) ImmunologicalDHB2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, ThyroglobulinMSW2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Thyroid AutoantibodyJZO2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Test, Creatinine, Over The CounterNFZ2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)LTK2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Test, Urine LeukocyteLJX1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test SystemLPS2Remanufacturer, Repackager or relabeleraccessdata.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
September 1, 2016K160429BC-5390 Auto Hematology AnalyzerGKZSubstantially EquivalentMindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
December 15, 2010K100060EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475KHSSubstantially EquivalentVital Diagnostics (Manufacturing) Ptyltdaccessdata.fda.gov
April 6, 2010K100673EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020JGSSubstantially EquivalentMedica Corp.accessdata.fda.gov
December 28, 2006K063276CLINITEK ADVANTUS, MODEL 1420JILSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
October 12, 2004K042173COULTER A T 5DIFF CAP PIERCE (CP)GKZSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
December 19, 2003K031947BAYER CLINITEK STATUS ANALYZERKQOSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
July 24, 2003K032013COULTER ACT 5DIFF AL HEMATOLOGY ANALYZERGKZSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
August 21, 2002K022603IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZERCEWSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
July 25, 2002K021504TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540FLESubstantially EquivalentTuttnauer U.S.A Co, Ltd.accessdata.fda.gov
February 9, 2001K993856TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EPFLESubstantially EquivalentTuttnauer U.S.A Co, Ltd.accessdata.fda.gov
November 12, 1997K962282TUTTNAUER PREVACUUM TABLE AUTOCLAVEFLESubstantially EquivalentTuttnauer U.S.A Co, Ltd.accessdata.fda.gov
October 29, 1997K973550TUTTNAUER TABLE-TOP AUTOCLAVEFLESubstantially EquivalentTuttnauer U.S.A Co, Ltd.accessdata.fda.gov
April 8, 1997K970227IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERJJESubstantially EquivalentDpc Cirrusaccessdata.fda.gov
April 20, 1995K945271ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEMJJESubstantially EquivalentBio-Chem Laboratory Systems, Inc.accessdata.fda.gov
September 29, 1992K924084ATAC 6000 CHEMISTRY ANALYZERJJESubstantially EquivalentBio-Chem Laboratory Systems, Inc.accessdata.fda.gov
June 4, 1985K850264TUTTNAUER PRE-VACUUM AUTOCLAVEFLESubstantially EquivalentTuttnauer Co. , Ltd.accessdata.fda.gov

Compare with other makers

Updated September 1, 2016. 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.