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

    WAKO CH50 LINEARITY SET

    K Number: K973055 · Decision Sep 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    16
    Applicant Total
    124
    Review Days
    41

    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 CH50 LINEARITY SET
    K Number
    K973055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wako Chemicals USA, Inc.
    Date Received
    August 15, 1997
    Decision Date
    September 25, 1997
    Product Code
    JIW
    Advisory Committee
    Clinical Chemistry
    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
    JIW Calibrator, Surrogate

    Similar 510(k) Clearances

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

    HUMAN CHORIONIC GONADOTROPIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLOW CYTOMETRY FITC/PE COMPENSATION KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCUSCAN MICROBEAD STANDARDS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACS COLLOID OSMOTIC PRESSURE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD

    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. →