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

    QUICKPAC II ONE STEP BARBITURATE TEST

    K Number: K980349 · Decision Mar 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    26
    Review Days
    34

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    Basic Information

    Device Name
    QUICKPAC II ONE STEP BARBITURATE TEST
    K Number
    K980349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntron Bioresearch, Inc.
    Date Received
    January 28, 1998
    Decision Date
    March 3, 1998
    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

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    Other Clearances by Syntron Bioresearch, Inc.

    K Number Device Name
    K993490 QUICKSTRIP ONE STEP OPIATES TEST
    K993491 QUICKPAC II ONE STEP OPIATES TEST
    K992990 QUICKPAC II ONE STEP COCAINE TEST
    K992748 DRUGCHECK X MULTIDRUG SCREENING DEVICE
    K992207 QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
    K990325 QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
    K983113 BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
    K981292 QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
    K981019 QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
    K974712 QUIKSTRIP ONE STEP BARBITURATE TEST
    Search all 26 clearances from Syntron Bioresearch, Inc. →