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

    N/T PROTEIN CONTROL PY

    K Number: K962407 · Decision Jul 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    145
    Review Days
    38

    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
    N/T PROTEIN CONTROL PY
    K Number
    K962407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    June 21, 1996
    Decision Date
    July 29, 1996
    Product Code
    GIL
    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
    GIL Plasma, Fibrinogen Control

    Similar 510(k) Clearances

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

    FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3

    FDA 510(k)
    FDA Class 2 ·Hematology

    FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3

    FDA 510(k)
    FDA Class 2 ·Hematology

    PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    N/T PROTEIN CONTROL PY

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    FIBRINOGEN CONTROL

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

    Other Clearances by Behring Diagnostics, Inc.

    K Number Device Name
    K973832 OPUS HLH CONTROLS
    K972929 N ANTISERUM TO HUMAN ALBUMIN
    K972840 N ANTISERUM TO HUMAN TRANSFERRIN
    K973202 MODIFICATION OF OPUS FERRITIN TEST SYSTEM
    K972316 OPUS D-DIMER
    K972116 VON WILLEBRAND REAGENT
    K972011 OPUS ETHANOL
    K971600 EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
    K971596 EMIT II OPIATES 300/2000 ASSAY
    K964595 OPUS PSA TEST SYSTEM
    Search all 145 clearances from Behring Diagnostics, Inc. →