BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Micro well group culture dish, 9-well; Micro well group culture dish, 16-well

    K Number: K150756 · Decision Jul 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    119

    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
    Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
    K Number
    K150756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hertart
    Date Received
    March 23, 2015
    Decision Date
    July 20, 2015
    Product Code
    MQK
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQK Labware, Assisted Reproduction

    Similar 510(k) Clearances

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

    SperSort™ Sperm Sorting Chip (IPG02)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    cryo-GO Vitrification Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    G-Vitri™ Vitrification Straw

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SpermAlign Sperm Separation Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Hertart

    K Number Device Name
    K123641 CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH