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

    ALB BCG REAGENT

    K Number: K852007 · Decision May 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    33
    Review Days
    23

    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
    ALB BCG REAGENT
    K Number
    K852007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Alpkem Corp.
    Date Received
    May 7, 1985
    Decision Date
    May 30, 1985
    Product Code
    CIX
    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
    CIX Bromcresol Green Dye-Binding, Albumin

    Similar 510(k) Clearances

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

    Core Metabolic

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Albumin BCG2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS XT Chemistry Products ALB-TP Slides

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

    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
    K890335 SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
    K890333 ALBUMIN REAGENT
    K883020 RFA-300 RAPID FLOW ANALYZER W/COMPUTER
    K860367 MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
    Search all 33 clearances from Alpkem Corp. →