BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    DC-LINEATE CAT. NO. SE-091

    K Number: K932555 · Decision Aug 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    77
    Review Days
    85

    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
    DC-LINEATE CAT. NO. SE-091
    K Number
    K932555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Chemicals, Ltd. (Usa)
    Date Received
    May 26, 1993
    Decision Date
    August 19, 1993
    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 Diagnostic Chemicals, Ltd. (Usa)

    K Number Device Name
    K022538 IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
    K974874 BILIRUBIN-SL (TOTAL) ASSAY
    K932556 AMMONIA ASSAY CAT. NO. 200-02
    K932766 HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
    K925877 DC-UIBC-CAL
    K912825 MAGNESIUM ASSAY KIT, CAT.# 100-12
    K895964 DCL SYPHILIS-M CATALOG NO. 600-80
    K895965 DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
    K904660 ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
    K901510 ENZYMATIC THEOPHYLLINE REAGENT, #500-82
    Search all 77 clearances from Diagnostic Chemicals, Ltd. (Usa) →