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

    BARBITURATE EIA ESSAY (MODIFICATION)

    K Number: K955928 · Decision Mar 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    66
    Review Days
    84

    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
    BARBITURATE EIA ESSAY (MODIFICATION)
    K Number
    K955928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Reagents, Inc.
    Date Received
    December 18, 1995
    Decision Date
    March 11, 1996
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

    Similar 510(k) Clearances

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

    Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CR3 Keyless Split Sample Cup Secobarbital- Methadone

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GenPrime Snap-Top Split Key Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD

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

    Other Clearances by Diagnostic Reagents, Inc.

    K Number Device Name
    K983268 MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
    K983812 NAPA EIA ASSAY
    K983323 DIGOXIN IMMUNOASSAY
    K983280 VANCOMYCIN EIA ASSAY
    K983159 DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
    K973102 LIDOCAINE EIA ASSAY
    K972835 50NG/ML COCAINE METABOLITE CALIBRATOR
    K972526 METHADONE EIA ASSAY
    K964212 QUINIDINE ENZYME IMMUNOASSAY
    K963835 DIGOXIN ENZYME IMMUNOASSAY
    Search all 66 clearances from Diagnostic Reagents, Inc. →