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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    WANO-TECH CORP.

    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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