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

    RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)

    K Number: K871269 · Decision Apr 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    157
    Review Days
    13

    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
    RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
    K Number
    K871269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    March 31, 1987
    Decision Date
    April 13, 1987
    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 Technicon Instruments Corp.

    K Number Device Name
    K914511 TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
    K914888 TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
    K914025 TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
    K912616 TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
    K912413 CHEM-LINK DATA BASE MANAGER
    K903825 DRUG OF ABUSE ANALYSIS SYSTEM
    K903305 TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
    K903824 DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
    K903306 TECHNICON CHEM I SYSTEM MAGNESIUM METHOD
    K901410 TECHNICON RA-2000(TM) SYSTEM
    Search all 157 clearances from Technicon Instruments Corp. →