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

    PRIMIDONE (FPIA) KIT

    K Number: K895567 · Decision Oct 20, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    9
    Review Days
    44

    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
    PRIMIDONE (FPIA) KIT
    K Number
    K895567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3680
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Tudor Laboratories, Inc.
    Date Received
    September 6, 1989
    Decision Date
    October 20, 1989
    Product Code
    LFT
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFT Fluorescent Immunoassay, Primidone

    Similar 510(k) Clearances

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

    PRIMIDONE FPIA REAGENT SET AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STRATUS PRIMIDONE FLUOROMETRIC ENZYME

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STRATUS PRIMIDONE FLOROMETRIC ENZY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADVANCE EMIT-AED PRIMEDONE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PRIMIDONE FLUORESCENT IMMUNOASSAY

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

    Other Clearances by Tudor Laboratories, Inc.

    K Number Device Name
    K921904 THYROXINE (FPIA) KIT
    K921903 THYROXINE CALIBRATOR KIT
    K913240 DIGITOXIN (FPIA) KIT
    K895572 N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT
    K895571 N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT
    K895569 VALPROIC ACID (FPIA) KIT
    K895570 VALPROIC ACID (FPIA) CALIBRATOR KIT
    K895568 PRIMIDONE (FPIA) CALIBRATOR KIT