BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYNTRON BIORESEARCH, INC.

    Reg #: 2025760 · FEI: 2025760 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    SYNTRON BIORESEARCH, INC.
    Registration Number
    2025760
    FEI Number
    2025760
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2774 LOKER AVE. WEST
    City
    CARLSBAD
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172257

    Owner / Operator

    Firm Name
    SYNTRON BIORESEARCH, INC.
    Operator Number
    2025760
    Address
    2774 LOKER AVE. WEST, --
    City
    Carlsbad
    State
    CA
    Postal Code
    92010
    Country
    US
    Correspondent
    Charles - Yu

    Products

    Device Name Product Code
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA

    Proprietary Names

    Ovulation Test, Frida Baby Well At Walgreens Early Result Pregnancy Test Two Samples Well at Walgreens ONE STEP PREGNANCY TEST One Sample Frida Early Detection Pregnancy Test AFIA Early Result Pregnancy Test Well At Walgreens Early Result Pregnancy Test Three Samples Well at Walgreens ONE STEP PREGNANCY TEST Two Samples Well at Walgreens ONE STEP PREGNANCY TEST Three Samples Equate Early Result Pregnancy Test First Response Pregnancy Test Cups SYNTRON QUIKSTRIP/E.Z. STRIP PREGNA Equate Digital Early Result Pregnancy Test One Step Menopause Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device