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

    CRYOSAN NORMAL SALINE

    K Number: K812309 · Decision Sep 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    37
    Applicant Total
    6
    Review Days
    30

    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
    CRYOSAN NORMAL SALINE
    K Number
    K812309
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Cryosan, Inc.
    Date Received
    August 17, 1981
    Decision Date
    September 16, 1981
    Product Code
    GIF
    Advisory Committee
    Hematology
    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
    GIF Diluent, Blood Cell

    Similar 510(k) Clearances

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

    KVM ISOTONIC FLUSH SOLUTION

    FDA 510(k)
    FDA Class 1 ·Hematology

    KVM ISOTONIC DILUENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    HYCEL QUICK-LYSING HEMOGLOBIN REAGENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    SYSMEX QUICKLYSER-II (QLS-200A)

    FDA 510(k)
    FDA Class 1 ·Hematology

    CELL-DYN ISOTONIC DILUENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    CELL-DYN DIFF. SCREEN ISOTONIC DILUENT

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

    Other Clearances by Cryosan, Inc.

    K Number Device Name
    K831953 INFUSION PUMP
    K830831 AUTOMATED BLOOD CELL SEPARATOR
    K822521 AUTOMATED BLOOD CELL SEPARATOR
    K813489 ROCKING/CIRCULATING CYTO-THERM II 3570
    K812311 CIRCULATING CYTO-THERMS