LogoFDA 510(k) Search
Search Filters

Search Results

Found 18 results

510(k) Data Aggregation

    K Number
    K991246
    Device Name
    FRUCTOSAMINE, MODEL FR 106-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-12-16

    (248 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The fructosamine reagent (R1), product No. FR10-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of fructosamine in serum, or plasma.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991761
    Device Name
    MAGNESIUM PRODUCT NO'S, 112-01, 112-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-09-02

    (101 days)

    Product Code
    JGJ
    Regulation Number
    862.1495
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Magnesium procedure is invitro Diagnostic use in the automated, quantitative determination of Magnesium in serum. Magnesium measurements are use in the diagnostics and treatment of hypomagnesemia (abnormally low levels of serum magnesium) and hypermagnesimia (abnormally high levels of serum magnesium).
    Device Description
    Not Found
    Ask a Question
    K Number
    K991762
    Device Name
    ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-09-02

    (101 days)

    Product Code
    CJE
    Regulation Number
    862.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Alkaline Phosphatase procedure is intended for Invitro Diagnostic use in the automated, in serum. Measurments of Alkaline quantitative determination of Alkaline Phosphatase or its isoenzymes are use in the diagnostics and treatment of liver, bone, Phosphatase parathyroid, and intestinal diseases.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991664
    Device Name
    LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-08-19

    (97 days)

    Product Code
    LBS
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This LDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of low-density lipoprotein-cholesterol (LDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991665
    Device Name
    HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-08-10

    (88 days)

    Product Code
    LBS
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This HDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of high-density lipoprotein-cholesterol (HDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991866
    Device Name
    BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-08-02

    (62 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The total and direct bilirubin reagents, product No. 122-01,122-02,122-03 and 122-04 are intended for Invitro Diagnostic use in the automated, quantitative determination of total and direct bilirubin in serum, or plasma.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991867
    Device Name
    INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-08-02

    (62 days)

    Product Code
    CEO
    Regulation Number
    862.1580
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro The morganic phosphords reagence from the determination of inorganic phosphate in serum, or plasma.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991870
    Device Name
    ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-07-30

    (59 days)

    Product Code
    CGZ, CEM, JGS
    Regulation Number
    862.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISE Electrolyte (Na+, K+ and Cl-) reagents, product No. 114-01, 1114-02 and 114-03 are intended for Invitro Diagnostic use in the automated, quantitative determination of sodium, potassium and chloride in serum, or plasma.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991663
    Device Name
    AST/SGOT
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-06-30

    (47 days)

    Product Code
    CIT
    Regulation Number
    862.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AST (SGOT) reagents, product No. 117-01 and 117-02 are intended for Invitro determination of AST (SGOT) in serum, or plasma.
    Device Description
    Not Found
    Ask a Question
    K Number
    K991666
    Device Name
    TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-06-30

    (47 days)

    Product Code
    JMO
    Regulation Number
    862.1415
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P. TOTAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Total Iron Binding Capacity (TIBC) reagents, product No. FE109-01, FE109-02 and The Total Iron Binding Capacity (TIDO) reagones processor seni-automated, quantitative determination of TIBC in serum, or plasma.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 2