BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2

    K Number: K780652 · Decision Jul 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    7
    Applicant Total
    7
    Review Days
    101

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    Basic Information

    Device Name
    HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2
    K Number
    K780652
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    The London Co.
    Date Received
    April 17, 1978
    Decision Date
    July 27, 1978
    Product Code
    JKS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

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