BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HOME ACCESS HEALTH CORP.

    Reg #: 1423455 · FEI: 3000206414 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    8

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    Registration Details

    Registration Name
    HOME ACCESS HEALTH CORP.
    Registration Number
    1423455
    FEI Number
    3000206414
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2401 Hassell Rd Ste 1510
    City
    Hoffman Est
    State
    IL
    ZIP
    60169
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141944

    Owner / Operator

    Firm Name
    PWNHealth Chicago, LLC
    Operator Number
    9031348
    Address
    2401 W. HASSELL RD., SUITE 1510
    City
    Hoffman Estates
    State
    IL
    Postal Code
    60169
    Country
    US
    Correspondent
    Alison Mancusi

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Automated Occult Blood Analyzer OOX
    Blood And Urine Collection Kit (Excludes Hiv Testing) OIB
    Colorimetric Method, Triglycerides JGY
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS

    Proprietary Names

    HomeAccess AiC Home Collection OC Auto Micro FOB accessa cholesterol panel

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device