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510(k) Data Aggregation

    K Number
    K023222
    Device Name
    ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2002-12-26

    (90 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ISOCARE ONE-STEP Sperm Processing Medium is intended for use in assisted reproductive technology procedures that involve the isolation, processing and transfer of sperm. Specifically, ISOCARE ONE-STEP Sperm Processing Medium is intended for use as a sperm isolation and processing medium in the isolation and processing of sperm during intrauterine and other reproductive technology procedures.
    Device Description
    ISOCARE ONE-STEP Sperm Processing Medium is a synthetic, defined culture medium composed of a mixture of salts and other physiologically compatible substances supplemented with 5mg/ml human serum albumin. ISOCARE ONE-STEP Sperm Processing Medium is intended for use in sperm processing procedures prior to intrauterine or other assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). ISOCARE ONE-STEP Medium uses a combined sodium bicarbonate/HEPES (J4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid () buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
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    K Number
    K003751
    Device Name
    HYALURONIDASE REAGENT, MODEL CAT#2212
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2001-01-17

    (43 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001967
    Device Name
    PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2000-08-14

    (47 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001113
    Device Name
    IVC THREE BLASTOCYST MEDIUM, CAT # 2007
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2000-06-13

    (68 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000989
    Device Name
    SPERM WASH MEDIUM, CAT# 2003/2005
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2000-06-08

    (72 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000937
    Device Name
    IVC TWO MEDIUM
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2000-05-25

    (63 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000938
    Device Name
    IVC ONE MEDIUM
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2000-05-25

    (63 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993484
    Device Name
    Q-HTF, CAT# 2001
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2000-05-25

    (224 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Q-HTF is intended for the retrieval, culture, transport, storage and transfer of human gametes and embryos. Q-HTF Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes and embryos. Specifically, Q-HTF is intended for use a a culture medium for the embryo after fertilization, when used with an incubator, and as a nedim to support in vitro fertilization. Q-HTF is intended to simulate the substances fourd in the human to female reproductive system.
    Device Description
    Q-HTF is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). Q-HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation. Q-HTF is intended for use as a culture medium, with appropriate protein supplementation, for the support of fertilized embryos. Fertilization is also allowed to occur in Q-HTF when in vitro fertilization techniques are used. The fertilized gamete is then allowed to grow in the media and supplement, which are replenished as needed, until the desired state of development, usually up to three days post fertilization. Since Q-HTF utilizes a sodium bicarbonate buffer system, it is intended to be used in those procedures that require a carbon dioxide atmosphere, as is found in the incubators used by assisted reproductive laboratories. Therefore Q-HTF is primarily used as a medium to support embryo growth, development and culture in vitro.
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    K Number
    K000939
    Device Name
    HTF-HEPES
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2000-05-04

    (42 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000940
    Device Name
    HUMAN SERUM ALBUMIN (HSA)
    Manufacturer
    INVITROCARE, INC.
    Date Cleared
    2000-05-04

    (42 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVITROCARE, INC.

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

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