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

    AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

    K Number: K972297 · Decision Jul 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    22
    Review Days
    28

    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
    AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    K Number
    K972297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trace America, Inc.
    Date Received
    June 19, 1997
    Decision Date
    July 17, 1997
    Product Code
    JFJ
    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
    JFJ Catalytic Methods, Amylase

    Similar 510(k) Clearances

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

    Amylase2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica CH Amylase_2 (AMY_2)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607

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

    Other Clearances by Trace America, Inc.

    K Number Device Name
    K003583 LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
    K980026 GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    K980028 ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    K980030 AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    K973869 TRACE REAGENT LINE FOR THE COBAS MIRA
    K974620 AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
    K971477 UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
    K971485 URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    K962723 TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
    K961984 PORPHOBILINOGEN (PBG)
    Search all 22 clearances from Trace America, Inc. →