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

    CHEMISTRY CONTROL & REFERENCE SERUMS

    K Number: K780204 · Decision Mar 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    96
    Applicant Total
    44
    Review Days
    24

    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
    CHEMISTRY CONTROL & REFERENCE SERUMS
    K Number
    K780204
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    February 7, 1978
    Decision Date
    March 3, 1978
    Product Code
    JJT
    Advisory Committee
    Clinical Chemistry
    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
    JJT Enzyme Controls (Assayed And Unassayed)

    Similar 510(k) Clearances

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

    SPOTCHECK BLOOD SPOT CONTROL, ASSAYED

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    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
    K810077 OMEGA 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
    Search all 44 clearances from Hyland Therapeutic Div., Travenol Laboratories →