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

    ELSA-PTH

    K Number: K950211 · Decision Apr 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    85
    Applicant Total
    9
    Review Days
    84

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    Basic Information

    Device Name
    ELSA-PTH
    K Number
    K950211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1545
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cis-Us, Inc.
    Date Received
    January 19, 1995
    Decision Date
    April 13, 1995
    Product Code
    CEW
    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
    CEW Radioimmunoassay, Parathyroid Hormone

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    Other Clearances by Cis-Us, Inc.

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    K871502 PERSONNEL PROTECTIVE SHIELD
    K865027 IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C
    K863778 VENTICIS II
    K860823 ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
    K860824 TSHK-NN RIA KIT