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510(k) Data Aggregation

    K Number
    K981457
    Device Name
    ALBP
    Manufacturer
    ABBOTT MFG., INC.
    Date Cleared
    1998-05-27

    (34 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Albumin BCP assay is used for the quantitation of albumin in human serum. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.
    Device Description
    Albumin BCP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to bromcresol purple. The absorbance of the complex is measured at 600 nm and is directly proportional to the albumin concentration in the sample.
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    K Number
    K981232
    Device Name
    CA
    Manufacturer
    ABBOTT MFG., INC.
    Date Cleared
    1998-05-18

    (45 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Calcium assay is used for the quantitation of calcium in human serum, plasma, or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms).
    Device Description
    Calcium is an in vitro diagnostic assay for the quantitative determination of calcium in serum, plasma, or urine. The Calcium assay is a clinical chemistry assay in which arsenazo-III dye reacts with calcium in an acid solution to form a blue-purple complex. The color developed is measured at 600 nm and is proportional to the calcium concentration in the sample.
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    K Number
    K981231
    Device Name
    CO2
    Manufacturer
    ABBOTT MFG., INC.
    Date Cleared
    1998-05-12

    (39 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carbon Dioxide (CO2) assay is used for the quantitation of carbon dioxide in human serum or plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
    Device Description
    Carbon Dioxide (CO2) is an in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum or plasma. The Carbon Dioxide assay is a clinical chemistry assay in which carbon dioxide, as bicarbonate (HCO3 ), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction, catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydorgenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). The resulting decrease in absorbance at 380 nm is proportional to the CO2 content of the sample.
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    K Number
    K965230
    Device Name
    ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
    Manufacturer
    ABBOTT MFG., INC.
    Date Cleared
    1997-07-03

    (184 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device is intended for intravenous fluid, blood and blood products, and for delivery of short-term epidural administration not exceeding 96 hours, in the hospital and home care environment.
    Device Description
    Not Found
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    K Number
    K971293
    Device Name
    LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
    Manufacturer
    ABBOTT MFG., INC.
    Date Cleared
    1997-06-27

    (81 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primary I.V. Set with Backcheck Valve is used for the delivery of I.V. fluids through the primary line or through the attachment of a secondary line into the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.
    Device Description
    Primary I.V. Set with Backcheck Valve
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