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

    CD-CHEX

    K Number: K920997 · Decision May 31, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    70
    Review Days
    90

    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
    CD-CHEX
    K Number
    K920997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Streck Laboratories, Inc.
    Date Received
    March 2, 1992
    Decision Date
    May 31, 1992
    Product Code
    GGL
    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
    GGL Control, White-Cell

    Similar 510(k) Clearances

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

    CD4 COUNT

    FDA 510(k)
    FDA Class 2 ·Hematology

    CD-CHEX PLUS BC

    FDA 510(k)
    FDA Class 2 ·Hematology

    CD-CHEX CD 34

    FDA 510(k)
    FDA Class 2 ·Hematology

    CD-CHEX + RBC

    FDA 510(k)
    FDA Class 2 ·Hematology

    CD-CHEX CD4 LOW

    FDA 510(k)
    FDA Class 2 ·Hematology

    COULTER POSITIVE CONTROL CELLS

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

    Other Clearances by Streck Laboratories, Inc.

    K Number Device Name
    K042587 RETIC-CHEX FOR CELL-DYN
    K040107 CYTO-CHEX BCT
    K040025 A1C-CELLULAR
    K023656 SICKLE-CHEX SOLUBILITY KIT
    K021922 MODIFICATION TO PARA 5X
    K020469 CAL-CHEX CD PLUS
    K013316 SICKLE-CHEX
    K011410 PARA 5X
    K001443 SUGAR CHEX ONE
    K000945 PARA 12 PLUS RETICS
    Search all 70 clearances from Streck Laboratories, Inc. →