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

    KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT

    K Number: K896440 · Decision Feb 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    37
    Applicant Total
    9
    Review Days
    99

    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
    KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT
    K Number
    K896440
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1645
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Kenlor Industries, Inc.
    Date Received
    November 9, 1989
    Decision Date
    February 16, 1990
    Product Code
    JIR
    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
    JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

    Similar 510(k) Clearances

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

    Minuteful-kidney test

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Minuteful - kidney test

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TECO MICROALBUMIN 2-1 COMBO STRIPS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING

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

    Other Clearances by Kenlor Industries, Inc.

    K Number Device Name
    K964014 KENLOR H. PYLORI CONTROL SERUM
    K952840 KENLOR LIQUID TOTAL URINE CONTROL
    K950326 KENLOR HUMAN SPINAL FLUID CONTROL
    K903338 KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL
    K890618 COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
    K890573 KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT
    K890576 KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
    K890577 KENLOR LIQUID URINE CONTROL