BEUDAMED
    Product Code: HZJ FDA class 1 21 CFR 864.1850

    Stain, Papanicolau

    Hematology

    Papanicolaou Stain (Pap stain) is a polychromatic staining method used in cytology to differentiate cell types in gynecological and non-gynecological smears, most notably in cervical cancer screening. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is HZJ, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

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    510(k)s
    15
    FEI Numbers
    30
    Registration Numbers
    30
    Unique Applicants
    6
    Years Active
    6

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    Basic Information

    Product Code
    HZJ
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    4

    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 15 510(k) clearances via K numbers.

    K Number Device Name
    K843427 GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
    K842739 PAP STAIN, EA-36
    K842735 PAP STAIN EA-65
    K842738 PAP STAIN EA-50
    K842736 PAP STAIN, OG-6
    K840054 PAPANICOLAOU STAIN SYS HT40
    K822035 VOLU-SOL GILLS EA
    K820027 MODIFIED EA 50
    K812087 EA 50
    K812086 EA 65
    K800325 VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65
    K800322 VOLU-SOL EA-50 STAIN
    K781588 PAPANICOLAOU STIAN OG-6
    K781583 PAPANICOLAOU STAIN :EA-50:
    K781582 PAPANICOLAOU STAIN EA-36

    FEI Numbers

    This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.