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510(k) Data Aggregation

    K Number
    K954326
    Device Name
    STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
    Manufacturer
    SOLARCARE TECHNOLOGIES CORP,INC.
    Date Cleared
    1996-07-23

    (312 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLARCARE TECHNOLOGIES CORP,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K954156
    Device Name
    STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
    Manufacturer
    SOLARCARE TECHNOLOGIES CORP,INC.
    Date Cleared
    1996-07-22

    (321 days)

    Product Code
    KQO
    Regulation Number
    862.2900
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLARCARE TECHNOLOGIES CORP,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K955905
    Device Name
    STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
    Manufacturer
    SOLARCARE TECHNOLOGIES CORP,INC.
    Date Cleared
    1996-05-30

    (153 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLARCARE TECHNOLOGIES CORP,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K954158
    Device Name
    STC DIAGNOSTICS AUTO-LYTE PH ASSAY
    Manufacturer
    SOLARCARE TECHNOLOGIES CORP,INC.
    Date Cleared
    1996-04-30

    (238 days)

    Product Code
    KQO
    Regulation Number
    862.2900
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLARCARE TECHNOLOGIES CORP,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K940048
    Device Name
    STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
    Manufacturer
    SOLARCARE TECHNOLOGIES CORP,INC.
    Date Cleared
    1996-03-19

    (804 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLARCARE TECHNOLOGIES CORP,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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