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

    BI-ASO SLIDE TEST

    K Number: K812060 · Decision Aug 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    36
    Applicant Total
    9
    Review Days
    23

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    Basic Information

    Device Name
    BI-ASO SLIDE TEST
    K Number
    K812060
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3720
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Biologics Intl., Inc.
    Date Received
    July 21, 1981
    Decision Date
    August 13, 1981
    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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    Other Clearances by Biologics Intl., Inc.

    K Number Device Name
    K882229 AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
    K823353 CARCINO-CEK
    K811374 BI-CRP LATEX TEST
    K811375 BI-RA SLIDE TEST
    K800605 ANA LATEX SLIDE TEST
    K791609 BE-SURE
    K791607 BETA-CELL
    K790898 PREG-TEX