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

    TEKTALLY II

    K Number: K771580 · Decision Sep 2, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    15

    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
    TEKTALLY II
    K Number
    K771580
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6160
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Scientific Products
    Date Received
    August 18, 1977
    Decision Date
    September 2, 1977
    Product Code
    GKM
    Advisory Committee
    Hematology
    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
    GKM Hand-Tally, Differential

    Similar 510(k) Clearances

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

    COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA

    FDA 510(k)
    FDA Class 1 ·Hematology

    DIGITAL-9 KEY LEUCOCYTE COUNTER

    FDA 510(k)
    FDA Class 1 ·Hematology

    MANUAL BLOOD CELL COUNTING DEVICE

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all