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

    IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530

    K Number: K872942 · Decision Jan 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    30
    Review Days
    168

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    Basic Information

    Device Name
    IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
    K Number
    K872942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Sciences, Inc.
    Date Received
    July 27, 1987
    Decision Date
    January 11, 1988
    Product Code
    LKQ
    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
    LKQ Antibody Igm,If, Cytomegalovirus Virus

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    Other Clearances by Clinical Sciences, Inc.

    K Number Device Name
    K900688 VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
    K883870 EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
    K883871 EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
    K891990 RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
    K883600 EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
    K883601 EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
    K874594 TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
    K860145 RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
    K860773 TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
    K854666 CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
    Search all 30 clearances from Clinical Sciences, Inc. →