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

    MCARTHUR MICROSCOPE, STANDARD METAL VERSION

    K Number: K864049 · Decision Oct 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    12

    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
    MCARTHUR MICROSCOPE, STANDARD METAL VERSION
    K Number
    K864049
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3600
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Portable Medical Laboratories, Inc.
    Date Received
    October 17, 1986
    Decision Date
    October 29, 1986
    Product Code
    IBJ
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IBJ Light, Microscope

    Similar 510(k) Clearances

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

    VIDEO ANALYZER 4000

    FDA 510(k)
    FDA Class 1 ·Pathology

    CELL COUNTING GRID GRATICULE

    FDA 510(k)
    FDA Class 1 ·Pathology

    THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION

    FDA 510(k)
    FDA Class 1 ·Pathology

    MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.

    FDA 510(k)
    FDA Class 1 ·Pathology

    PATHOLOGY INSTRUMENTATION & ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Pathology

    2XC MICROSCOPE

    FDA 510(k)
    FDA Class 1 ·Pathology
    View all

    Other Clearances by Portable Medical Laboratories, Inc.

    K Number Device Name
    K882101 HEMOGLOBIN SCREENING DEVICE
    K874190 CELL COUNTING GRID GRATICULE
    K871671 URINOSCOPY FUNNEL
    K854735 MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.
    K844476 PORTABLE DIAGNOSTIC LABORATORY
    K844475 SPECIMEN COLLECTION & TRANSPORT SYSTEM
    K844442 RAPID DIAGNOSTIC KIT
    K844473 HAND-HELD SLIDE READER