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

    STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS

    K Number: K981497 · Decision Oct 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    22
    Review Days
    185

    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
    STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
    K Number
    K981497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Steritec Products Mfg Co, Inc.
    Date Received
    April 27, 1998
    Decision Date
    October 29, 1998
    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 Steritec Products Mfg Co, Inc.

    K Number Device Name
    K200252 Getinge Assured MI Steam Migrating Integrator
    K133549 STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
    K133322 STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
    K132372 STERITEC GREEN CARD PACK BOWIE-DICK TEST
    K122945 STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
    K122555 STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
    K111150 STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
    K103000 SMART READ BIOLOGICAL TEST PACK
    K072408 EMU-GRAPH EMULATOR, MODEL CI 131
    K000502 STEAM/EO RECORD CARD, MODEL CI 121
    Search all 22 clearances from Steritec Products Mfg Co, Inc. →