BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HEMATOLOGY DATA MANAGEMENT SYS

    K Number: K821534 · Decision Jun 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    4
    Applicant Total
    11
    Review Days
    17

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HEMATOLOGY DATA MANAGEMENT SYS
    K Number
    K821534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biovation, Inc.
    Date Received
    May 24, 1982
    Decision Date
    June 10, 1982
    Product Code
    JGP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JGP Lowry (Colorimetric), Total Protein

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JGP), ordered by most recent decision date.

    MICROPROTEIN REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS CHEMISTRY PRODUCTS UPRO SLIDES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROTEINMETER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MICRO LOWRY PROTEINTEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Biovation, Inc.

    K Number Device Name
    K925528 BIOVATION K-MANAGER
    K923844 LYRIS 100/120 LABORATORY INFORMATION SYSTEM
    K915071 DIFFERENTIAL COUNTING BOARD
    K853026 BIOVATION MAX DATA MANAGEMENT SYSTEM
    K842401 CHEMISTRY CONSOLE
    K831830 LYRIS MODULAR INFO SYSTEM
    K812604 BIOVATION URINALYSIS REPORTER
    K792045 BIOVATION NEPHELOMETER
    K790862 BIOVATION DIGITAL URINOMETER
    K781644 ANTIBIOTIC NEPHELOMETER
    Search all 11 clearances from Biovation, Inc. →