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

    ERYTHROPOIETIN IMMUNOASSAY KIT

    K Number: K952559 · Decision May 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    19
    Applicant Total
    15
    Review Days
    362

    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
    ERYTHROPOIETIN IMMUNOASSAY KIT
    K Number
    K952559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7250
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nichols Institute
    Date Received
    June 2, 1995
    Decision Date
    May 29, 1996
    Product Code
    GGT
    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
    GGT Assay, Erythropoietin

    Similar 510(k) Clearances

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

    Access EPO

    FDA 510(k)
    FDA Class 2 ·Hematology

    ADVIA Centaur Erythropoietin (EPO) assay

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCESS EPO ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    IMMULITE EPO, MODEL #'S LKEPZ & LKEP1

    FDA 510(k)
    FDA Class 2 ·Hematology

    ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY

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

    Other Clearances by Nichols Institute

    K Number Device Name
    K952505 INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)
    K946247 IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3
    K950524 NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
    K932650 ERYTHROPOIETIN IMMUNOASSAY KIT
    K931600 CHEMILUMINESCENCE FREE T3 IMMUNOASSAY
    K931777 APO A-1 CHEMILUMINESCENCE ASSAY
    K931601 CHEMILUMINESCENCE DHEA-S IMMUNOASSAY
    K926396 ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT
    K931311 THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT
    K930777 THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT
    Search all 15 clearances from Nichols Institute →