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

    SULFOSALICYLIC ACID, 3% W/V

    K Number: K842915 · Decision Aug 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    12
    Applicant Total
    50
    Review Days
    16

    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
    SULFOSALICYLIC ACID, 3% W/V
    K Number
    K842915
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1645
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E K Ind., Inc.
    Date Received
    July 25, 1984
    Decision Date
    August 10, 1984
    Product Code
    JIQ
    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
    JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

    Similar 510(k) Clearances

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

    TOTAL PROTEIN URINE/CSF GEN.3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AUSAM TOTAL ALBUMIN ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEMOCHEK URINE COLLECTION KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR

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

    Other Clearances by E K Ind., Inc.

    K Number Device Name
    K842931 DRABKIN REAGENT
    K842938 ACETIC ACID 1% V/V
    K842934 DECOLORIZING FLUIC, ACID-ALCOHOL 3%
    K842937 ACETIC ACID 2% V/V
    K842935 ACETIC ACID, 5% V/V
    K842936 ACETIC ACID, 3% V/V
    K842927 LIGHT GREEN SF 1%
    K842919 SCHIFF REAGENT FUCHSIN-SULFUROUS ACID
    K842926 METHYLENE BLUE STAIN, LOEFFLER
    K842933 CARBOL-FUCHSIN, ZIEHL-NEEDSEN
    Search all 50 clearances from E K Ind., Inc. →