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

    ALPHA PLASTIC PLASMA BOTTLE

    K Number: K810897 · Decision Sep 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    15
    Applicant Total
    8
    Review Days
    173

    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
    ALPHA PLASTIC PLASMA BOTTLE
    K Number
    K810897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Alpha Therapeutic Corp.
    Date Received
    April 3, 1981
    Decision Date
    September 23, 1981
    Product Code
    KSR
    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
    KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

    Similar 510(k) Clearances

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

    KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEROYAL SURGICAL, UMBILICUP

    FDA 510(k)
    FDA Class 2 ·Hematology

    BLOOD FREEZING BAG

    FDA 510(k)
    FDA Class 2 ·Hematology

    PLASMA FLEX

    FDA 510(k)
    FDA Class 2 ·Hematology

    HAEMONETICS 1000ML COMPONENT BAG

    FDA 510(k)
    FDA Class 2 ·Hematology

    HAEMONETICS 600 ML. COMPONENT BAG

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

    Other Clearances by Alpha Therapeutic Corp.

    K Number Device Name
    K970225 ALPHA MICRON 20/40 MICROAGGREGATE FILTER
    K955515 ALPHA MICRON 20 MICROAGGREGATE FILTER
    K854920 THERAPY CASSETTS
    K854441 STUART GILMAN'S WEIGHT LOSS PLAN
    K833294 ALPHA Y-RECIPIENT SET
    K820447 ALPHA PLASMA TRANSFER SET
    K810761 ALPHA MICRON-40 FILTER