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

    HAEM-C PLUS BLOOD REFERENCE CONTROLS

    K Number: K821956 · Decision Jul 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    11
    Applicant Total
    10
    Review Days
    30

    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
    HAEM-C PLUS BLOOD REFERENCE CONTROLS
    K Number
    K821956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Baker Instructions Corp.
    Date Received
    June 30, 1982
    Decision Date
    July 30, 1982
    Product Code
    JCN
    Advisory Committee
    Hematology
    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
    JCN Control, Cell Counter, Normal And Abnormal

    Similar 510(k) Clearances

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

    PARA TECH PLUS RETICS

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH

    FDA 510(k)
    FDA Class 2 ·Hematology

    CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE

    FDA 510(k)
    FDA Class 2 ·Hematology

    STAK-CHEX

    FDA 510(k)
    FDA Class 2 ·Hematology

    CELL-DYN 3000 CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    TRI-COUNT 16

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Baker Instructions Corp.

    K Number Device Name
    K882612 SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER
    K873596 BAKER TDM THEOPHYLLINE ASSAY
    K870603 SYSTEM 9000 AUTOMATED CELL COUNTER
    K854173 UCD URINE SPECIMEN COLLECTOR
    K850386 SYSTEM 8000 CELL COUNTER
    K833116 SPIRIT CHEMISTRY SYSTEM
    K832716 ENCORE CHEMISTRY ANALYZER
    K830641 ENCORE CHEMISTRY ANALYZER
    K811694 CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT