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

    ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02

    K Number: K991762 · Decision Sep 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    123
    Applicant Total
    18
    Review Days
    101

    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
    ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
    K Number
    K991762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A.P. Total Care, Inc.
    Date Received
    May 24, 1999
    Decision Date
    September 2, 1999
    Product Code
    CJE
    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
    CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

    Similar 510(k) Clearances

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

    Tru Liver Health Test Panel

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Alkaline Phosphatase

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Alkaline Phosphatase2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Yumizen C1200 ALP, Yumizen C1200 Albumin

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALP IFCC Gen.2

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

    Other Clearances by A.P. Total Care, Inc.

    K Number Device Name
    K991246 FRUCTOSAMINE, MODEL FR 106-01
    K991761 MAGNESIUM PRODUCT NO'S, 112-01, 112-02
    K991664 LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
    K991665 HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
    K991867 INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
    K991866 BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
    K991870 ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
    K991663 AST/SGOT
    K991666 TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
    K991247 URIC ACID, MODEL UA112-01
    Search all 18 clearances from A.P. Total Care, Inc. →