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

    SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.

    K Number: K890335 · Decision Feb 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    33
    Review Days
    25

    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
    SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
    K Number
    K890335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Alpkem Corp.
    Date Received
    January 23, 1989
    Decision Date
    February 17, 1989
    Product Code
    CGE
    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
    CGE Orthotoluidine, Glucose

    Similar 510(k) Clearances

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

    GLUCOSE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GLUCOSE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIRECT GLUCOSE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIRECT GLUCOSE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KING DIAGNOSTICS GLUCOSE-O TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    6% ORTHO LOLIUDINE REAGENT IN GLACID ACI

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

    Other Clearances by Alpkem Corp.

    K Number Device Name
    K894011 TOTAL GALACTOSE
    K891070 PHENYLALANINE (NINHYDRIN REACTION)
    K890334 TOTAL CHOLESTEROL REAGENT
    K890337 TRIGLYCERIDES - GPO REAGENT
    K890336 GLUCOSE (GOD) REAGENT
    K890332 RFA/2 RAPID FLOW ANALYZER W/COMPUTER
    K890333 ALBUMIN REAGENT
    K883020 RFA-300 RAPID FLOW ANALYZER W/COMPUTER
    K860367 MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
    K851990 INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
    Search all 33 clearances from Alpkem Corp. →