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

    PROCHEM EXT CHEMICAL INTEGRATOR

    K Number: K062651 · Decision Mar 15, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    15
    Review Days
    189

    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
    PROCHEM EXT CHEMICAL INTEGRATOR
    K Number
    K062651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Raven Biological Laboratories, Inc.
    Date Received
    September 7, 2006
    Decision Date
    March 15, 2007
    Product Code
    JOJ
    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
    JOJ Indicator, Physical/Chemical Sterilization Process

    Similar 510(k) Clearances

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

    LF Process Indicator Tape for Steam Sterilization

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISINTEK™ PA Test Strips

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VERIFY STEAM Integrating Indicator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Green Card Bowie-Dick Test (BD115)

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

    Other Clearances by Raven Biological Laboratories, Inc.

    K Number Device Name
    K082756 RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR
    K053212 RAVEN PROPACT
    K050591 MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
    K041784 RAVEN PROTEST - EO
    K041386 RAVEN PROTEST - STEAM
    K032914 MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
    K031114 PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
    K020026 RAVEN BACTERIAL SPORE STRIPS
    K994381 PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
    K971430 PROSPORE II
    Search all 15 clearances from Raven Biological Laboratories, Inc. →