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

    GAMMA FETAL BLEED SCREENING TEST

    K Number: K820647 · Decision May 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    21
    Review Days
    64

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    Basic Information

    Device Name
    GAMMA FETAL BLEED SCREENING TEST
    K Number
    K820647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7455
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Gamma Biologicals, Inc.
    Date Received
    March 9, 1982
    Decision Date
    May 12, 1982
    Product Code
    LIM
    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
    LIM Test, Screening, For D Positive Fetal Rbc'S

    Similar 510(k) Clearances

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

    FETAL D TECTION KIT

    FDA 510(k)
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    K813342 GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
    K820072 FE-CULT PLUS
    K811752 FE-CULT PLUS
    K802533 GAMMA LEWIS BLOOD GROUP SUBSTANCE
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