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

    RAPIDONE-BUPRENORPHINE TEST

    K Number: K060760 · Decision Aug 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    30
    Review Days
    139

    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
    RAPIDONE-BUPRENORPHINE TEST
    K Number
    K060760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Bio Medica Corp.
    Date Received
    March 21, 2006
    Decision Date
    August 7, 2006
    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 American Bio Medica Corp.

    K Number Device Name
    K170222 Rapid Tox Cup II
    K073078 RAPID TOX CUP
    K053422 RAPIDONE-COCAINE-150 TEST
    K053359 RAPIDTOX
    K041696 RAPID READER
    K041712 'RAPIDTEC 4' TEST
    K030835 'RAPID ONE' - PROPOXYPHENE TEST
    K023869 'RAPIDTEC'-5M-MULTIPLE DIP TEST
    K021114 'RAPIDTEC' 5A MULTIPLE DIP TEST
    K014101 RAPIDONE-OXY TEST
    Search all 30 clearances from American Bio Medica Corp. →