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

    BINAX STREP A

    K Number: K863908 · Decision Dec 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    104
    Applicant Total
    30
    Review Days
    76

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    Basic Information

    Device Name
    BINAX STREP A
    K Number
    K863908
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Binax, Inc.
    Date Received
    October 7, 1986
    Decision Date
    December 22, 1986
    Product Code
    GTZ
    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
    GTZ Antisera, All Groups, Streptococcus Spp.

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    Other Clearances by Binax, Inc.

    K Number Device Name
    K090301 BINAXNOW PBP2A TEST, MODEL 890-000
    K091766 CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
    K090964 BINAXNOX STAPHYLOCOCCUS AUREUS TEST
    K091489 CLEARVIEW ADVANCED STREP A , MODEL 737-430
    K083744 BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
    K092223 MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
    K080003 BINAXNOW G6PD TEST
    K062109 BINAXNOW INFLUENZA A & B TEST
    K053126 BINAXNOW INFLUENZA A & B TEST
    K041049 BINAXNOW INFLUENZA A & B TEST
    Search all 30 clearances from Binax, Inc. →