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

    EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229

    K Number: K010934 · Decision Apr 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    19
    Review Days
    23

    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
    EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
    K Number
    K010934
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syva Co., Dade Behring, Inc.
    Date Received
    March 28, 2001
    Decision Date
    April 20, 2001
    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 Syva Co., Dade Behring, Inc.

    K Number Device Name
    K011920 EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
    K011620 EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
    K011605 EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
    K011300 EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
    K011306 EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
    K011161 MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
    K011289 EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
    K011163 MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
    K011166 MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
    K011164 MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
    Search all 19 clearances from Syva Co., Dade Behring, Inc. →