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510(k) Data Aggregation

    K Number
    K150887
    Device Name
    Para-Fix C&S Medium
    Date Cleared
    2015-05-29

    (57 days)

    Product Code
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL CHEMICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Para-Fix™ C&S Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.
    Device Description
    Para-Fix C&S Medium is a non-nutritive, buffered, isotonic solution with a pH indicator added. The medium also contains agar and sodium thioglycolate to maintain a low oxygen tension for the preservation of anaerobic species. The phenol red indicator will turn yellow when the solution is acidic and the conditions are not optimal for recovery of the intended organisms. Each 30 mL vial contains 15 ml of solution and a built in sample collection spoon. The kit is available with or without a multilingual instruction sheet and re-sealable bag.
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    K Number
    K141506
    Device Name
    MCC Para-Fix CARY BLAIR MEDIUM
    Date Cleared
    2015-02-25

    (264 days)

    Product Code
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL CHEMICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Para-FixTM Cary Blair Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.
    Device Description
    Para-Fix Cary Blair Medium is a non-nutritive, buffered, isotonic solution with a pH indicator added. The medium also contains agar and sodium thioglycolate to maintain a low oxygen tension for the preservation of anaerobic species. The phenol red indicator will turn yellow when the solution is acidic and the conditions are not optimal for recovery of the intended organisms. Each 30 mL vial contains 15 ml of solution and a built in sample collection spoon. The kit is available with or without a multilingual instruction sheet and re-sealable bag.
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    Ask a specific question about this device

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