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

    GAMMA LEWIS BLOOD GROUP SUBSTANCE

    K Number: K802533 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    21
    Review Days
    28

    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
    GAMMA LEWIS BLOOD GROUP SUBSTANCE
    K Number
    K802533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9160
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Gamma Biologicals, Inc.
    Date Received
    October 15, 1980
    Decision Date
    November 12, 1980
    Product Code
    KSX
    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
    KSX Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

    Similar 510(k) Clearances

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

    GAMMA PI BLOOD GROUP SUBSTANCE

    FDA 510(k)
    FDA Class 2 ·Hematology

    P1 BLOOD GROUP SUBSTANCE

    FDA 510(k)
    FDA Class 2 ·Hematology

    BLOOD GROUP SUBSTANCE B

    FDA 510(k)
    FDA Class 2 ·Hematology

    BLOOD GROUP SUBSTANCE A

    FDA 510(k)
    FDA Class 2 ·Hematology

    BLOOD GROUP SUBSTANCE A,B

    FDA 510(k)
    FDA Class 2 ·Hematology

    LEWIS BLOOD GROUP SUBSTANCE

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

    Other Clearances by Gamma Biologicals, Inc.

    K Number Device Name
    K864207 DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
    K861016 GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
    K832473 GAMMA SLIDE TEST FOR PREGNANCY
    K820647 GAMMA FETAL BLEED SCREENING TEST
    K813342 GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
    K820072 FE-CULT PLUS
    K811752 FE-CULT PLUS
    K802534 GAMMA PI BLOOD GROUP SUBSTANCE
    K800658 RST-SERIES CONTROL
    K792582 POLY-LEC SYSTEM
    Search all 21 clearances from Gamma Biologicals, Inc. →