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

    ROTALOK SURGICAL HAND TABLE

    K Number: K850251 · Decision Feb 28, 1985
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    7
    Review Days
    37

    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
    ROTALOK SURGICAL HAND TABLE
    K Number
    K850251
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Fairleigh Dickinson Laboratories, Inc.
    Date Received
    January 22, 1985
    Decision Date
    February 28, 1985
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Other Clearances by Fairleigh Dickinson Laboratories, Inc.

    K Number Device Name
    K896032 MODIFIED ELISA FOR CHLAMYDIA
    K895187 FDL, INC.'S TRANSPORT SYSTEM
    K883266 FDL ELISA FOR CHLAMYDIA
    K881502 BREWER GEL FOR CAMPYLOBACTER
    K875362 BREWER GEL FOR ANAEROBES
    K853307 DIRECT ELISA FOR HERPES SIMPLEX VIRUS