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

    EKTACHEM CLINICAL CHEM. SLIDES

    K Number: K840151 · Decision Mar 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    238
    Review Days
    69

    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
    EKTACHEM CLINICAL CHEM. SLIDES
    K Number
    K840151
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1520
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Eastman Kodak Company
    Date Received
    January 13, 1984
    Decision Date
    March 22, 1984
    Product Code
    CED
    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
    CED 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

    Similar 510(k) Clearances

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

    PHOSPHORUS TEST ITEM NUMBER 65416

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BTC URINE LH ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PHOSPHORUS IL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SANDARE FAST 340 PHOSPHORUS PROCEDURE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SIGMA PROCEDURE 265-UV

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INORGANIC PHOSPHORUS REAGENTS

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

    Other Clearances by Eastman Kodak Company

    K Number Device Name
    K060550 KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
    K060137 KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
    K060079 KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
    K060055 KODAK PACS
    K053347 KODAK CARESTREAM PACS
    K051483 KODAK DIRECTVIEW DR SYSTEM DETECTOR
    K051258 KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
    K042159 KODAK COLOR MEDICAL IMAGER 1000
    K042158 KODAK MEDICAL IMAGER 300
    K040378 KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
    Search all 238 clearances from Eastman Kodak Company →