BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Analytical Control Systems

    Reg #: 1825740 · FEI: 1825740 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Analytical Control Systems
    Registration Number
    1825740
    FEI Number
    1825740
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9058 Technology Drive
    City
    Fishers
    State
    IN
    ZIP
    46038
    Country
    US

    Regulatory Submissions

    510(k) Number
    K930477

    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
    Calibrator, Primary JIS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Whole Blood Hemoglobin Determination KHG

    Proprietary Names

    Angiotensin Converting Enzyme Calibrator Normal and Abnormal Angiotensin Converting Enzyme Control HC-108DE G-6-PDH Depressed HC-106 F Normal HC-107 Gal-1-Put Normal HC-127 AG Philadelphia HC-111EL A2 Elevated HC-108IN G-6-PDH Intermediate HC-119 AFC HC-104 AS HC-102N NAFSC HC-120 AD HC-107DE Gal-1-Put Depressed HC-102 AFSC HC-103 AF HC-106EL F Abnormal HC-111 A2 Normal HC-121 Hgb Fractions (AS, AC, AF, A2) HC-108 G-6-PDH Normal HC-105 AC HC-117 AE HC-118 AFS HC-110 Total Hgb Control HC-110LIN TTL Hgb Linearity

    Establishment Types

    Manufacture Medical Device