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

    ACTH STANDARD MATRIX

    K Number: K842099 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    94
    Review Days
    84

    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
    ACTH STANDARD MATRIX
    K Number
    K842099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    May 25, 1984
    Decision Date
    August 17, 1984
    Product Code
    JIT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JIT Calibrator, Secondary

    Similar 510(k) Clearances

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

    VITROS Immunodiagnostic Products Insulin Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CalSet IGF-1

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Abbott ARCHITECT Free T3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G Progesterone-N Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G FSH-N Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G LH Calibrators

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

    Other Clearances by Diagnostic Systems Laboratories, Inc.

    K Number Device Name
    K061758 ACTIVE RENIN IRMA
    K020945 AXSYM INTACT PTH, MODEL 2G06
    K020128 ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
    K002128 ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
    K001086 FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
    K990138 DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
    K981871 C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
    K973243 ACTIVE PSA ELISA (DSL-10-9700)
    K973244 ACTIVE PSA IRMA (DSL-9700)
    K981607 ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
    Search all 94 clearances from Diagnostic Systems Laboratories, Inc. →