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

    SAFESTRIP

    K Number: K955107 · Decision Aug 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    145
    Registration Numbers
    145
    Same Product Code
    399
    Applicant Total
    1
    Review Days
    282

    Basic Information

    Device Name
    SAFESTRIP
    K Number
    K955107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    FIREHOUSE MEDICAL, INC.
    Date Received
    November 8, 1995
    Decision Date
    August 16, 1996
    Product Code
    CGA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CGA Glucose Oxidase, Glucose

    Similar 510(k) Clearances

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

    YSI 2900C Biochemistry Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EasyStat 300

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Cholestech LDX ™ System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT G cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT CG8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GEM Premier ChemSTAT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all