BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SCITECK Diagnostics

    Reg #: 3004875840 · FEI: 3004875840 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    SCITECK Diagnostics
    Registration Number
    3004875840
    FEI Number
    3004875840
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    317 Rutledge Road
    City
    Fletcher
    State
    NC
    ZIP
    28732
    Country
    US

    Regulatory Submissions

    510(k) Number
    K940768

    Owner / Operator

    Firm Name
    Sciteck
    Operator Number
    10050379
    Address
    317 Rutledge Road
    City
    Fletcher
    State
    NC
    Postal Code
    28732
    Country
    US
    Correspondent
    Jack V Smith

    Products

    Device Name Product Code
    Glutaraldehyde IFT
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Automated Urinalysis System KQO
    Calibrator, Secondary JIT

    Proprietary Names

    aD PERFECT SVT Aldehydes Reagent SVT Creatinine Reagent cR PERFECT AutoUA UA PERFECT AutoUA Automated Urinalysis System - AUA-450

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility