BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL

    K Number: K922723 · Decision Sep 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    36
    Applicant Total
    5
    Review Days
    105

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    Basic Information

    Device Name
    TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
    K Number
    K922723
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3720
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Simplicity Diagnostics, Inc.
    Date Received
    June 5, 1992
    Decision Date
    September 18, 1992
    Product Code
    GTQ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GTQ Antistreptolysin - Titer/Streptolysin O Reagent

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    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;

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    OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT

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    TURBIQUANT ASL

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    BECKMAN ANTI-STREPTOLYSIN O KIT

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    ACCUTEX ASO LATEX TEST

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    BECKMAN ANTISTREPTOLYSIN O, MODIFICATION

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    Other Clearances by Simplicity Diagnostics, Inc.

    K Number Device Name
    K970100 TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
    K922725 TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL
    K922722 TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
    K922726 TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL