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

    EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.

    K Number: K821963 · Decision Jul 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    27
    Review Days
    26

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    Basic Information

    Device Name
    EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.
    K Number
    K821963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Immunoassay Laboratories, Inc.
    Date Received
    July 1, 1982
    Decision Date
    July 27, 1982
    Product Code
    GGP
    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
    GGP Test, Qualitative And Quantitative Factor Deficiency

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    K903441 MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
    K903508 LABELLING CHANGES TO IMPRES-MB-X
    K901450 MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
    K890609 IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
    K890543 IMPRES-MB REAGENT A AND REAGENT B
    K883432 IMMUNOCCULT-LXI
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    Search all 27 clearances from Intl. Immunoassay Laboratories, Inc. →