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

    CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE

    K Number: K897177 · Decision Mar 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    89
    Review Days
    90

    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
    CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE
    K Number
    K897177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nova Biomedical Corp.
    Date Received
    December 27, 1989
    Decision Date
    March 27, 1990
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

    Similar 510(k) Clearances

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

    VITROS Chemistry Products Calibrator Kit 3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYSTEM CALIBRATER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN

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

    Other Clearances by Nova Biomedical Corp.

    K Number Device Name
    K100602 NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
    K101633 NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
    K091547 NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
    K070960 NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
    K070255 NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
    K070068 NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
    K063821 NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
    K061830 STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
    K060345 NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
    K041016 NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
    Search all 89 clearances from Nova Biomedical Corp. →