BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PARAMAX IRON REAGENT

    K Number: K881104 · Decision Apr 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    66
    Applicant Total
    505
    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
    PARAMAX IRON REAGENT
    K Number
    K881104
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    March 15, 1988
    Decision Date
    April 28, 1988
    Product Code
    JIY
    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
    JIY Photometric Method, Iron (Non-Heme)

    Similar 510(k) Clearances

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

    DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SENTINEL IRON LIQUID

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITALAB IRON REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IRON-PC-SL ASSAY MODEL # 151-10, 151-26

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Baxter Healthcare Corp

    K Number Device Name
    K190910 PrisMax System Version 2
    K163530 PrisMax Control Unit
    K130531 ULTRAFUSE
    K132734 NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
    K130245 LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
    K123874 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
    K123868 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
    K121092 FLOWEASE [SUBCUTANEOUS] INFUSION SET
    K113227 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
    K111217 ADDITIVE CAP
    Search all 505 clearances from Baxter Healthcare Corp →