BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RHIGENE MESACUP-2 TEST RNP, MODEL M7741

    K Number: K022017 · Decision Aug 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    15
    Review Days
    55

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    Basic Information

    Device Name
    RHIGENE MESACUP-2 TEST RNP, MODEL M7741
    K Number
    K022017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rhigene, Inc.
    Date Received
    June 20, 2002
    Decision Date
    August 14, 2002
    Product Code
    LKO
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKO Anti-Rnp Antibody, Antigen And Control

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    Other Clearances by Rhigene, Inc.

    K Number Device Name
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    K033528 MESACUP-2 TEST JO-1, MODEL 10756
    K031308 RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
    K022018 RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
    K011068 RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
    K000336 RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
    K000751 RHIGENE MESACUP2 TEST- SSB
    K000755 RHIGENE MESACUP2 TEST- SM
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