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510(k) Data Aggregation

    K Number
    K042641
    Device Name
    CHEMVIEW-10
    Manufacturer
    CENOGENICS CORP.
    Date Cleared
    2005-01-07

    (102 days)

    Product Code
    JIL, KHE
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENOGENICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine. These metabolites are useful in the evaluation of renal, urinary and metabolic disorder.
    Device Description
    CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine.
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    K Number
    K030533
    Device Name
    ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
    Manufacturer
    CENOGENICS CORP.
    Date Cleared
    2003-04-17

    (62 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENOGENICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Accunate Home Pregnancy Test is an over-the-counter (OTC) one-step qualitative test for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
    Device Description
    ACCUNATE™ONE-STEP, ACCUNATE™ONE-STEP CASSETTE and ACCUNATE-CHOICE™ are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine or in urine and serum for the early detection of pregnancy.
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    K Number
    K992397
    Device Name
    ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
    Manufacturer
    CENOGENICS CORP.
    Date Cleared
    1999-08-26

    (38 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    CENOGENICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACCUNATE™-ONE STEP and ACCUNATE™-ONE STEP CASSETTE are rapid lateral flow colloldal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
    Device Description
    ACCUNATE™-ONE STEP and ACCUANTE™-ONE STEP CASSETTE are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
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