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

    HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

    K Number: K180559 · Decision Oct 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    17
    Review Days
    242

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    Basic Information

    Device Name
    HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
    K Number
    K180559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3309
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elitechgroup
    Date Received
    March 1, 2018
    Decision Date
    October 29, 2018
    Product Code
    PGI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

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    Other Clearances by Elitechgroup

    K Number Device Name
    K171401 ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
    K153644 ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
    K151113 ELITech Clinical Systems CALCIUM ARSENAZO
    K151552 ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
    K141265 ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
    K132399 ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
    K130765 ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
    K122177 ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
    K122858 ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
    K122083 ELITECH CLINICAL SYSTEMS CK NAC SL
    Search all 17 clearances from Elitechgroup →