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

    SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT

    K Number: K852946 · Decision Sep 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    34
    Applicant Total
    158
    Review Days
    81

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    Basic Information

    Device Name
    SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
    K Number
    K852946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    July 11, 1985
    Decision Date
    September 30, 1985
    Product Code
    DLZ
    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
    DLZ Enzyme Immunoassay, Phenobarbital

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