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

    WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET

    K Number: K030320 · Decision Apr 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    124
    Review Days
    71

    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
    WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
    K Number
    K030320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wako Chemicals USA, Inc.
    Date Received
    January 30, 2003
    Decision Date
    April 11, 2003
    Product Code
    JIS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JIS Calibrator, Primary

    Similar 510(k) Clearances

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

    DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION IRON CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    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
    Search all 124 clearances from Wako Chemicals USA, Inc. →