BEUDAMED
    Product Code: LKH FDA class 1 21 CFR 866.3120

    Antisera, Immunoperoxidase, Chlamydia Spp.

    Microbiology

    Antisera, Immunoperoxidase, Chlamydia Spp. are immunoperoxidase-labeled antisera used in histological or cytological staining procedures to identify Chlamydia species in tissue or cell specimens, aiding in the diagnosis of chlamydial infections. This device is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is LKH, regulated under 21 CFR 866.3120, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    8
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    7
    Years Active
    9

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    Basic Information

    Product Code
    LKH
    Device Class
    FDA class 1
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K910644 IPAZYME (TM) CHLAMYDIA IGG-IGA
    K901975 IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)
    K882674 IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
    K893669 CELLMATICS SHLAMYDIA DETECTION SYSTEM
    K852869 SELECTICULT-CHLAMYDIA
    K842151 CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT
    K830688 COMBION SKIN TEST
    K820390 HISTOSET IMMUNOPEROXIDASE TISSURE KIT