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

    ACON STREP A TWIST TEST DEVICE

    K Number: K023766 · Decision Feb 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    43
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    ACON STREP A TWIST TEST DEVICE
    K Number
    K023766
    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
    November 12, 2002
    Decision Date
    February 10, 2003
    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
    K090057 ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K061559 ACON URINALYSIS REAGENT STRIPS
    K020313 ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
    K010582 ACON STREP A RAPID TEST STRIP
    K980736 ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST