BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Immuchem PHE-MW EIA

    Reg #: 2419955 · FEI: 2419955 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MP BIOMEDICALS DIAGNOSTICS DIVISION
    Registration Number
    2419955
    FEI Number
    2419955
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    29525 Fountain Pkwy
    City
    Solon
    State
    OH
    ZIP
    44139
    Country
    US

    Regulatory Submissions

    510(k) Number
    K926106

    Owner / Operator

    Firm Name
    MP BIOMEDICALS LLC
    Operator Number
    9057708
    Address
    29525 FOUNTAIN PARKWAY
    City
    Solon
    State
    OH
    Postal Code
    44139
    Country
    US
    Correspondent
    Walter S Zawadzkas

    Products

    Device Name Product Code
    Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine JNB

    Proprietary Names

    Immuchem PHE-MW EIA

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device