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

    GENTAMICIN LIQUID CONTROL SERUM

    K Number: K792262 · Decision Dec 18, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    82
    Applicant Total
    7
    Review Days
    39

    Basic Information

    Device Name
    GENTAMICIN LIQUID CONTROL SERUM
    K Number
    K792262
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    HEMOMETRIX
    Date Received
    November 9, 1979
    Decision Date
    December 18, 1979
    Product Code
    LAS
    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
    LAS Drug Specific Control Materials

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LAS), ordered by most recent decision date.

    CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    QUANTIMETRIX NICOSURE COTININE URINE CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MAS IMMUNOSUPPRESSANT CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    DRI OXYCODONE ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MICROGENICS CYCLOSPORINE CONTROL KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology
    View all

    Other Clearances by HEMOMETRIX

    K Number Device Name
    K800037 PLATELET RETENTION (ADHESION) COLUMNS
    K792261 GENTAMICIN CONTROL SERUM
    K792263 TOBRAMYCIN CONTROL SERUM
    K792260 AMIKACIN LIQUID CONTROL SERUM
    K792264 TOBRAMYCIN LIQUID CONTROL SERUM
    K792259 AMIKACIN CONTROL SERUM