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

    MICRO-STRIP FOR AMPHETAMINE METABOLITES

    K Number: K974611 · Decision Mar 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    10
    Review Days
    99

    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
    MICRO-STRIP FOR AMPHETAMINE METABOLITES
    K Number
    K974611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microdiagnostics, Inc.
    Date Received
    December 11, 1997
    Decision Date
    March 20, 1998
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

    Similar 510(k) Clearances

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

    DRI Ecstasy Plus Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Quidel Triage® TOX Drug Screen, 94600

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

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

    Other Clearances by Microdiagnostics, Inc.

    K Number Device Name
    K011952 DRUGS OF ABUSE MULTI-TEST STRIP
    K991516 MICRO-STRIP FOR MARIJUANA METABOLITES
    K991505 MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
    K981388 MICRO-STRIP FOR COCAINE METABOLITES
    K973761 MICRO-STRIP FOR OPIATE METABOLITES
    K932304 MICRO EIA FOR AMPHETAMINE METABOLITES
    K923468 MICRO EIA FOR OPIATE METABOLITES
    K914533 MICRO EIA FOR COCAINE METABOLITES
    K914490 MICRO EIA FOR MARIJUANA METABOLITES