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

    ROM PLUS

    K Number: K110605 · Decision Nov 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    9
    Review Days
    266

    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
    ROM PLUS
    K Number
    K110605
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Innovations, LLC
    Date Received
    March 2, 2011
    Decision Date
    November 23, 2011
    Product Code
    NQM
    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
    NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).

    Similar 510(k) Clearances

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

    AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1

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

    Other Clearances by Clinical Innovations, LLC

    K Number Device Name
    K250298 Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
    K250897 Koala Intrauterine Pressure Catheter (IPC-5000E)
    K223900 babyLance Safety Heelstick (BLM, BLN, BLP)
    K153591 ebb Complete Tamponade System
    K150573 ebb Complete Tamponade System
    K140163 KOALA TOCO
    K131781 CLEARVIEW TOTAL
    K061539 GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE