BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    InActiv Blue

    K Number: K221547 · Decision Jun 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    16
    Applicant Total
    4
    Review Days
    746

    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
    InActiv Blue
    K Number
    K221547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2950
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fertipro NV
    Date Received
    May 27, 2022
    Decision Date
    June 11, 2024
    Product Code
    QBD
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QBD Microbial Nucleic Acid Storage And Stabilization Device

    Similar 510(k) Clearances

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

    Puritan PurSafe Plus Collection and Transport System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PPH Saliva Collection Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sample Preservative Fluid

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Molecular Transport Media - MTM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sample preservation solution

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DNA/RNA Shield SafeCollect Saliva Collection kit

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Fertipro NV

    K Number Device Name
    K242640 FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
    K070135 VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
    K053494 OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE