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

    CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS

    K Number: K944606 · Decision Nov 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    11
    Review Days
    72

    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
    CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS
    K Number
    K944606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman-Diagnostic Systems Group
    Date Received
    September 19, 1994
    Decision Date
    November 30, 1994
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

    Similar 510(k) Clearances

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

    Labcorp Fentanyl Urine Visual Test

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Evidence MultiSTAT DOA Urine MultiPlex

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LZI Buprenorphine II Enzyme Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SEFRIA™ Hydrocodone Oral Fluid

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LZI Fentanyl III Enzyme Immunoassay

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

    Other Clearances by Beckman-Diagnostic Systems Group

    K Number Device Name
    K945522 I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS
    K944605 CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM
    K944604 CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS
    K942676 SYNCHRON CX3 DELTA
    K934293 BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
    K934068 BECKMAN DIRECT BILIRUBIN REAGENT
    K936184 VIGIL PRX CHEMISTRY CONTROL
    K934271 BECKMAN SYNCHRON LACTATE REAGENT
    K934046 BECKMAN CHOLESTEROL REAGENT
    K934467 BECKMAN CX AMMONIA/ALCOHOL CONTROL
    Search all 11 clearances from Beckman-Diagnostic Systems Group →