BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.

    K Number: K810077 · Decision Jan 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    44
    Review Days
    15

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    Basic Information

    Device Name
    OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
    K Number
    K810077
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    January 13, 1981
    Decision Date
    January 28, 1981
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DIF Drug Mixture Control Materials

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    Other Clearances by Hyland Therapeutic Div., Travenol Laboratories

    K Number Device Name
    K820835 ALUMINA SILICA-ACTIVATED PARTIAL THROM
    K820192 HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM
    K812220 NEPHELOMETRIC SOLID TURBIDITY STANDARD
    K810078 Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
    K802610 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
    K791113 LOW IONIC STRENGTH SOLUTION (LISS)
    K790249 TEST CELLS
    K781225 GLOBULIN TEST, HUMAN THYROXINE BINDING
    K780962 AUTOMATED ENZYME
    K780785 DILUTOR TRANSPORTER
    Search all 44 clearances from Hyland Therapeutic Div., Travenol Laboratories →