BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gastroccult Test for Gastric Occult Blood and pH Developer/15 mL (PN 66115)

    Reg #: 1017835 · FEI: 1017835 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    1017835
    FEI Number
    1017835
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    740 WEST 83RD ST.
    City
    HIALEAH
    State
    FL
    ZIP
    33014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K880499

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    David G Davis

    Products

    Device Name Product Code
    Reagent, Occult Blood KHE

    Proprietary Names

    Gastroccult Test for Gastric Occult Blood and pH Developer/15 mL (PN 66115) Hemoccult SENSA Sensitive Test for Enhanced Detection of Fecal Occult Blood Single Slides (PN 64152) Hemoccult II Serial Test For Routine Screening for Fecal Occult Blood Dispensapak Patient Kits (PN 61100) Hemoccult Routine Screening Test for Fecal Occult Blood Single Slides (60152) Hemoccult SENSA Sensitive Test for Enhanced Detection of Fecal Occult Blood Single Slides (PN 64151) Hemoccult II Serial Test For Routine Screening for Fecal Occult Blood Slides (PN 61200) Hemoccult II Serial Test For Routine Screening for Fecal Occult Blood Dispensapak Plus (PN 61130) Hemoccult Routine Screening Test for Fecal Occult Blood Tape with Developer (63202) Gastroccult Test for Gastric Occult Blood and pH 40 Test Slides (PN 66040) Hemoccult II SENSA Sensitive Test for Enhanced Detection of Fecal Occult Blood Dispensapak Plus (PN 64130) Hemoccult Routine Screening Test for Fecal Occult Blood Single Slides (PN 60151) Gastroccult 40 Applicator Straws (PN 66140) Hemoccult Routine Screening Test for Fecal Occult Blood Developer (PN 62115) Hemoccult Mailing Pouches (PN 62200) Hemoccult SENSA Sensitive Test for Enhanced Detection of Fecal Occult Blood Developer (PN 64115)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)