BEUDAMED
    Product Code: JIO FDA class 2 21 CFR 864.6550

    Blood, Occult, Colorimetric, In Urine

    Hematology

    Colorimetric Blood (Occult) in Urine is a hematology test system that uses colorimetric peroxidase-like reactions to detect the presence of hemoglobin or occult blood in urine, used in the screening for urinary tract pathology including hematuria, infection, and renal disease. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JIO, regulated under 21 CFR 864.6550, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    11
    FEI Numbers
    46
    Registration Numbers
    46
    Unique Applicants
    10
    Years Active
    35

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    Basic Information

    Product Code
    JIO
    Device Class
    FDA class 2
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Review Panel
    HE
    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 11 510(k) clearances via K numbers.

    K Number Device Name
    K232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
    K111999 HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
    K111221 MISSION U500 URINE ANALYZER
    K082811 URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
    K083724 WIENER LAB. URINE STRIP 10 AND 11
    K040703 URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
    K023297 URS-1B (BLOOD TEST)
    K921495 DIA STRIPS SYSTEM, MODIFIED
    K913005 BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
    K905396 HEMASTIX REAGENT STRIPS
    K893894 CHARISE CHARLES REAGENT BLOOD STRIPS

    FEI Numbers

    This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.