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510(k) Data Aggregation

    K Number
    K000257
    Device Name
    IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    2000-02-23

    (27 days)

    Product Code
    JFH
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    JFH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981573
    Device Name
    UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1998-09-15

    (134 days)

    Product Code
    JFH
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    JFH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of PAP level in human serum to aid in the management and monitoring the effectiveness of various therapeutic treatments of prostate cancer patients. (for Professional use only)
    Device Description
    The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA).
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    K Number
    K964756
    Device Name
    PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
    Manufacturer
    WANO-TECH CORP.
    Date Cleared
    1997-04-23

    (147 days)

    Product Code
    JFH
    Regulation Number
    862.1020
    Why did this record match?
    Product Code :

    JFH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    This method uses anti-human PAP mouse monoclonal antibodies to inhibit PAP activity which results in much higher specificity than is obtained with tartaric acid inhibition method. With this test kit, the PAP is completely eliminated from ACP in calculating the level of PAP. High sensitivity composite substrate 2,6-doichloro-4-acetylphenyl phosphate (DCAP-P) is used, making it simple and fast to use with general purpose automated analyzers.
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