BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

    K Number: K981634 · Decision Oct 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    33
    Applicant Total
    8
    Review Days
    158

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    Basic Information

    Device Name
    BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
    K Number
    K981634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biocircuits Corp.
    Date Received
    May 8, 1998
    Decision Date
    October 13, 1998
    Product Code
    LTJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

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    Other Clearances by Biocircuits Corp.

    K Number Device Name
    K980819 BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
    K963770 BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS
    K961566 BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
    K961792 BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
    K952719 BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
    K952751 BIOCIRCUITS IOS T4/TU TEST CARTRIDGES
    K953837 BIOCIRCUITS IOS T4 TEST CARTRIDGE