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

    G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE

    K Number: K020489 · Decision May 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    41
    Review Days
    90

    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
    G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
    K Number
    K020489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tosoh Medics, Inc.
    Date Received
    February 13, 2002
    Decision Date
    May 14, 2002
    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.

    VARIANT II B-THALASSEMIA

    FDA 510(k)
    FDA Class 2 ·Hematology

    VARIANT BETA-THALASSEMIA SHORT PROGRAM

    FDA 510(k)
    FDA Class 2 ·Hematology

    GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

    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 Tosoh Medics, Inc.

    K Number Device Name
    K023893 ST AIA-PACK CEA ENZYME IMMUNOASSAY
    K023894 ST AIA-PACK AFP ENZYME IMMUNOASSAY
    K023091 ST AIA-PACK TESTOSTERONE ASSAY
    K023891 ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
    K012820 AIA-PACK CTNI 2ND-GEN ASSAY
    K011434 G7 AUTOMATED HPLC ANALYZER
    K010796 AIA-PACK BRCA, ST AIA PACK BRCA
    K992365 AIA-PACK FOLATE ASSAY
    K990431 AIA-PACK CA 125
    K991252 AIA-PACK FT3 ASSAY
    Search all 41 clearances from Tosoh Medics, Inc. →