BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOLOGICAL INDICATOR - KEMMED & BIOSURE

    K Number: K802228 · Decision Dec 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    3
    Review Days
    90

    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
    BIOLOGICAL INDICATOR - KEMMED & BIOSURE
    K Number
    K802228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Kem Medical Products Corp.
    Date Received
    September 10, 1980
    Decision Date
    December 9, 1980
    Product Code
    FRC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRC Indicator, Biological Sterilization Process

    Similar 510(k) Clearances

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

    Celerity 5 HP Biological Indicator (LCB052)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Celerity™ 20 HP Biological Indicator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Terragene® Bionova® BT20 Biological Indicator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Celerity Incubator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Kem Medical Products Corp.

    K Number Device Name
    K181788 Lead-free Chemical Indicators for Steam Sterilization
    K802229 CHEMICAL INDICATOR - KEM MED & BIO SURE