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

    HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY

    K Number: K945748 · Decision Jun 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    265
    Applicant Total
    51
    Review Days
    196

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    Basic Information

    Device Name
    HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
    K Number
    K945748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hycor Biomedical, Inc.
    Date Received
    November 23, 1994
    Decision Date
    June 7, 1995
    Product Code
    DHB
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DHB System, Test, Radioallergosorbent (Rast) Immunological

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    Other Clearances by Hycor Biomedical, Inc.

    K Number Device Name
    K081217 HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
    K080322 HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
    K022944 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
    K022945 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
    K965094 HYCOR ALLERGEN DISC
    K962730 HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
    K962720 HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
    K962729 HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
    K962578 HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
    K962722 HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
    Search all 51 clearances from Hycor Biomedical, Inc. →