BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CONTOX HEAVYMETALS CONTROL

    K Number: K830234 · Decision Feb 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    4
    Review Days
    24

    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
    CONTOX HEAVYMETALS CONTROL
    K Number
    K830234
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Kaulson Laboratories, Inc.
    Date Received
    January 25, 1983
    Decision Date
    February 18, 1983
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DIF Drug Mixture Control Materials

    Similar 510(k) Clearances

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

    Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MULTICHEM WBT

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology
    View all

    Other Clearances by Kaulson Laboratories, Inc.

    K Number Device Name
    K830493 PROTOPORPHYRIN ZN CONTROL
    K830492 CONTOX DURG CONTROL
    K830494 CONTOX DRUG SCREEN CONTROL