BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SYNERMED CREATINE KINASE REAGENT KIT

    K Number: K930932 · Decision May 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    45
    Review Days
    77

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    Basic Information

    Device Name
    SYNERMED CREATINE KINASE REAGENT KIT
    K Number
    K930932
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Synermed, Inc.
    Date Received
    February 23, 1993
    Decision Date
    May 11, 1993
    Product Code
    CGS
    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
    CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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    Other Clearances by Synermed, Inc.

    K Number Device Name
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    K971491 SYNERMED IR 200 CHEMISTRY ANALYZER
    K962479 SYNERMED ISE REAGENTS
    K963939 SYNERMED DIRECT BILIRUBIN REAGENT KIT
    K960793 SYNERMED ENZYMATIC CO2 REAGENT KIT
    K953395 SYNERMED CALCIUM REAGENT KIT
    K952179 SYNERMED ISE REAGENTS
    K943924 CREATININE-PO REAGENT KIT
    K941091 SYNERMED AMYLASE REAGENT KIT
    Search all 45 clearances from Synermed, Inc. →