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510(k) Data Aggregation

    K Number
    K970664
    Device Name
    GLUCOSE REAGENT
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-08-01

    (161 days)

    Product Code
    CFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glucose Reagent is to be used to aid in the diagnosis of diabetes mellitus and other associated with glucose abnormalities.
    Device Description
    Not Found
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    K Number
    K971309
    Device Name
    UREA
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-08-01

    (115 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UREA reagent (BUN) is to be used to aid in the determination of liver and kidney functions and congestive heart failure and other diseases associated with protein catabolism.
    Device Description
    Not Found
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    K Number
    K971072
    Device Name
    CHOLESTEROL REAGENT
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-06-20

    (88 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
    Device Description
    CHOLESTEROL REAGENT
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    K Number
    K970867
    Device Name
    URIC ACID REAGENT
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-04-21

    (42 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971005
    Device Name
    TRIGLYCERIDES
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-04-21

    (33 days)

    Product Code
    JGY
    Regulation Number
    862.1705
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K964915
    Device Name
    MAGNESIUM
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-03-26

    (107 days)

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

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964913
    Device Name
    IRON REAGENT
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-02-20

    (73 days)

    Product Code
    JIY
    Regulation Number
    862.1410
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K965134
    Device Name
    ALT/SGPT
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-02-18

    (57 days)

    Product Code
    CKA
    Regulation Number
    862.1030
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964914
    Device Name
    ALKALINE PHOSPHATASE
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-02-04

    (57 days)

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

    DERMA MEDIA LAB., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K965126
    Device Name
    AST/SGOT
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-01-17

    (25 days)

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

    DERMA MEDIA LAB., INC.

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

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