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

    KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT

    K Number: K780982 · Decision Jun 22, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    45
    Applicant Total
    9
    Review Days
    8

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT
    K Number
    K780982
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5680
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Cis Radiopharmaceuticals, Inc.
    Date Received
    June 14, 1978
    Decision Date
    June 22, 1978
    Product Code
    DDR
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DDR Myoglobin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    Access Myoglobin

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Cis Radiopharmaceuticals, Inc.

    K Number Device Name
    K791860 FERRITIN RIA KIT
    K792063 FOLLICLE STIMULATING HORMONE (FSH) KIT
    K791202 RIA KIT FOR TRYPSIN
    K792000 LUTEINIZING HORMONE (LH) RIA
    K791051 PROGESTERONE RADIOIMMUNOASSAY KIT
    K790003 RIA KIT, PROLACTIN
    K771878 IRIDIUM 192 WIRES & PINS
    K760251 SET, ORAL ADMINISTRATION