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

    ACON STREP A RAPID TEST STRIP

    K Number: K010582 · Decision May 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    43
    Applicant Total
    6
    Review Days
    69

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    Basic Information

    Device Name
    ACON STREP A RAPID TEST STRIP
    K Number
    K010582
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acon Laboratories Co.
    Date Received
    February 27, 2001
    Decision Date
    May 7, 2001
    Product Code
    GTY
    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
    GTY Antigens, All Groups, Streptococcus Spp.

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    Other Clearances by Acon Laboratories Co.

    K Number Device Name
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    K061559 ACON URINALYSIS REAGENT STRIPS
    K023766 ACON STREP A TWIST TEST DEVICE
    K020313 ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
    K980736 ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST