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

    REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

    K Number: K001606 · Decision Oct 5, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    3
    Review Days
    134

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    Basic Information

    Device Name
    REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
    K Number
    K001606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Repromedix Corp.
    Date Received
    May 24, 2000
    Decision Date
    October 5, 2000
    Product Code
    JLW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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    Other Clearances by Repromedix Corp.

    K Number Device Name
    K001603 REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
    K001607 REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)