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Data / Medical devices / United States / Supply Max Ny Inc

Supply Max Ny Inc: FDA-registered device maker in Suffern, NY, United States, 3 510(k) clearances

Supply Max Ny Inc is registered with the FDA (registration 3033967997) in Suffern, NY, United States. It lists 31 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 11, 2006. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Supply Max Ny Inc
FDA registration number
3033967997
Address
100 Ny 59 Suite 119, Suffern, NY, United States, 10901
Owner or operator
Supply Max NY Inc (10093056)
Roles
Repackager or relabeler
First device listed
March 31, 2025
Registered through
2026
Brand names listed
CoaguChek XS 24 tests

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Folic, RadioimmunoassayCGN2Repackager or relabeleraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Repackager or relabeleraccessdata.fda.gov
Calibrator, SecondaryJIT2Repackager or relabeleraccessdata.fda.gov
Calibrators, Drug MixtureDKB2Repackager or relabeleraccessdata.fda.gov
Collector, OstomyEXB1Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, GentamicinLCD2Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RubellaLFX2Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD2Repackager or relabeleraccessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)LGR2Repackager or relabeleraccessdata.fda.gov
Fluorescence Polarization Immunoassay, TheophyllineLGS2Repackager or relabeleraccessdata.fda.gov
Fluorescent Immunoassay, TobramycinLCR2Repackager or relabeleraccessdata.fda.gov
Ige, Antigen, Antiserum, ControlDGC2Repackager or relabeleraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Repackager or relabeleraccessdata.fda.gov
Radioassay, Triiodothyronine UptakeKHQ2Repackager or relabeleraccessdata.fda.gov
Radioassay, Vitamin B12CDD2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Parathyroid HormoneCEW2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Repackager or relabeleraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Repackager or relabeleraccessdata.fda.gov
System, Test, Thyroid AutoantibodyJZO2Repackager or relabeleraccessdata.fda.gov
Test, Time, ProthrombinGJS2Repackager or relabeleraccessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test SystemLPS2Repackager or relabeleraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Repackager 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
August 11, 2006K060978COAGUCHEK XS SYSTEMGJSSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 2, 2004K041133MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZERCDDSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
April 7, 1981K810807HOLLISEAL OSTOMY SKIN BARRIEREXBSubstantially EquivalentHollister, Inc.accessdata.fda.gov

Compare with other makers

Updated August 11, 2006. 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.