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

    COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.

    K Number: K872397 · Decision Jul 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    296
    Review Days
    29

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    Basic Information

    Device Name
    COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
    K Number
    K872397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    June 22, 1987
    Decision Date
    July 21, 1987
    Product Code
    LGQ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LGQ Fluorescence Polarization Immunoassay, Phenobarbital

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