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

    WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR

    K Number: K993162 · Decision Nov 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    124
    Review Days
    51

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    Basic Information

    Device Name
    WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
    K Number
    K993162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wako Chemicals USA, Inc.
    Date Received
    September 22, 1999
    Decision Date
    November 12, 1999
    Product Code
    DDG
    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
    DDG Transferrin, Antigen, Antiserum, Control

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    Other Clearances by Wako Chemicals USA, Inc.

    K Number Device Name
    K100464 UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
    K080125 APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
    K080123 APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
    K061775 WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
    K062368 WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
    K053132 WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
    K053131 WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
    DEN050002 LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
    K042551 MULTI-CHEM CALIBRATOR A
    K042550 MULTI-LIPID CALIBRATOR
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