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

    NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)

    K Number: K141244 · Decision Sep 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    6
    Review Days
    118

    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
    NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)
    K Number
    K141244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    North American Science Assoc., Inc.
    Date Received
    May 14, 2014
    Decision Date
    September 9, 2014
    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 North American Science Assoc., Inc.

    K Number Device Name
    K132291 NAMSA CHEMICAL PROCESS
    K113221 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
    K113302 NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
    K983451 CHALLENGE TEST PACK
    K962649 SPORTROL RAPID STERILITY INDICATOR