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

    ELISA CMV IGM

    K Number: K914789 · Decision Mar 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    82
    Review Days
    133

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    Basic Information

    Device Name
    ELISA CMV IGM
    K Number
    K914789
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sclavo, Inc.
    Date Received
    October 23, 1991
    Decision Date
    March 4, 1992
    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 Sclavo, Inc.

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    K895847 CREATININE 340 (ENZYMATIC)
    K880049 CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
    K880199 CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
    K873496 ATYPICAL CHOLINESTERASE
    K884035 SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
    K884649 TOTAL IRON BINDING CAPACITY TEST
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