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510(k) Data Aggregation

    K Number
    K030850
    Device Name
    ENHANCE HUMAN SERUM ALBUMIN
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2003-04-08

    (22 days)

    Product Code
    MQL
    Regulation Number
    884.6180
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    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HSA is intended as a protein supplement for in-vitro mammalian-cell culture media. These procedures include in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation.
    Device Description
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    K Number
    K023655
    Device Name
    ENHANCE HTF MEDIUM WITH HEPES
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2002-12-13

    (44 days)

    Product Code
    MQL
    Regulation Number
    884.6180
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    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENHANCE HTF with HEPES is a medium that is used for in vitro procedures involving the manipulation of gametes and embryos not requiring the use of a CO2 incubator.
    Device Description
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    K Number
    K023717
    Device Name
    SPERM WASH MEDIUM WITH GENTAMICIN
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2002-12-13

    (38 days)

    Product Code
    MQL
    Regulation Number
    884.6180
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    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.
    Device Description
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    K Number
    K020490
    Device Name
    PBS, PBSW WITH CATIONS AND PHENOL RED
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2002-03-28

    (43 days)

    Product Code
    MQL
    Regulation Number
    884.6180
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    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Phosphate Buffered Saline With Cations and Phenol Red (PBSW) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s). Phosphate Buffered Saline (PBS) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).
    Device Description
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    K Number
    K011481
    Device Name
    10% PVP; 10% PVP IN EBSS SOLUTION
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2001-07-02

    (49 days)

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

    CONCEPTION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011573
    Device Name
    HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2001-07-02

    (42 days)

    Product Code
    MQL
    Regulation Number
    884.6180
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    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hyaluronidase in HTF Medium is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
    Device Description
    Hyaluronidase in HTF Medium; Hyaluronidase in EBSS Medium
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    K Number
    K011462
    Device Name
    OIL FOR TISSUE CULTURE
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2001-06-13

    (30 days)

    Product Code
    MQL
    Regulation Number
    884.6180
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    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993140
    Device Name
    WATER FOR TISSUE CULTURE, MODELS 1500
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2000-08-02

    (317 days)

    Product Code
    MTW
    Regulation Number
    884.6170
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    Applicant Name (Manufacturer) :

    CONCEPTION TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures. It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.
    Device Description
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