BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HC-103 AF

    Reg #: 1825740 · FEI: 1825740 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Analytical Control Systems
    Registration Number
    1825740
    FEI Number
    1825740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9058 Technology Drive
    City
    Fishers
    State
    IN
    ZIP
    46038
    Country
    US

    Regulatory Submissions

    510(k) Number
    K802569

    Owner / Operator

    Firm Name
    ANALYTICAL CONTROL SYSTEMS
    Operator Number
    1825740
    Address
    9058 TECHNOLOGY DR., --
    City
    Fishers
    State
    IN
    Postal Code
    46038
    Country
    US
    Correspondent
    Eric A BONDERMAN

    Products

    Device Name Product Code
    Whole Blood Hemoglobin Determination KHG

    Proprietary Names

    HC-103 AF HC-111 A2 Normal HC-108DE G-6-PDH Depressed HC-106EL F Abnormal HC-118 AFS HC-104 AS HC-107 Gal-1-Put Normal HC-102N NAFSC HC-106 F Normal HC-107DE Gal-1-Put Depressed HC-105 AC HC-111EL A2 Elevated HC-117 AE HC-119 AFC HC-127 AG Philadelphia HC-120 AD HC-108IN G-6-PDH Intermediate HC-121 Hgb Fractions (AS, AC, AF, A2) HC-102 AFSC HC-108 G-6-PDH Normal

    Establishment Types

    Manufacture Medical Device