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

    PARAMAX(R) PHENYTOIN REAGENT

    K Number: K932686 · Decision Nov 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    43
    Applicant Total
    72
    Review Days
    176

    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
    PARAMAX(R) PHENYTOIN REAGENT
    K Number
    K932686
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    June 3, 1993
    Decision Date
    November 26, 1993
    Product Code
    DIP
    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
    DIP Enzyme Immunoassay, Diphenylhydantoin

    Similar 510(k) Clearances

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

    ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROCHE ONLINE TDM PHENYTOIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANDOX PHENYTOIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6

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

    Other Clearances by Baxter Diagnostics, Inc.

    K Number Device Name
    K934458 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K950817 DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
    K935704 DRIED GRAM-NEGATIVE MIC//COMBO PANELS
    K950570 STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
    K945235 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K941030 DRIED GRAM-NEGATIVE CEFPODOXIME
    K940917 LORACARBEF GRAM-NAGATIVE PANELS
    K941459 GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
    K941317 DRIED GRAM NEGATIVE/CEFMETAZOLE
    K942089 MICRODILUTION/LORACARBEF PANELS
    Search all 72 clearances from Baxter Diagnostics, Inc. →