BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

    K Number: K924496 · Decision Nov 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    7
    Review Days
    73

    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
    GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT
    K Number
    K924496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Drew Scientific , Ltd.
    Date Received
    September 4, 1992
    Decision Date
    November 16, 1992
    Product Code
    JPD
    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
    JPD Hemoglobin A2 Quantitation

    Similar 510(k) Clearances

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

    G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE

    FDA 510(k)
    FDA Class 2 ·Hematology

    VARIANT II B-THALASSEMIA

    FDA 510(k)
    FDA Class 2 ·Hematology

    VARIANT BETA-THALASSEMIA SHORT PROGRAM

    FDA 510(k)
    FDA Class 2 ·Hematology

    COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    COLUMNMATE(TM) BETA-THAL CAT. NO. 4515

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

    Other Clearances by Drew Scientific , Ltd.

    K Number Device Name
    K060510 DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
    K043378 DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
    K012152 DS30 HCY BLOOD COLLECTION TUBES
    K982003 DS30 HCY HOMOCYSTEINE ASSAY KIT
    K933287 745 GLYCOMAT
    K920198 GLYCOMAT HAEMOGLOBIN ANALYSER