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510(k) Data Aggregation

    K Number
    K100596
    Device Name
    CRYOPETTE
    Manufacturer
    MID-ATLANTIC DIAGNOSTICS, INC.
    Date Cleared
    2010-12-06

    (279 days)

    Product Code
    MQK, MOK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MID-ATLANTIC DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
    Device Description
    The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette. The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling. The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.
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    K Number
    K041435
    Device Name
    THE STRIPPER PGD
    Manufacturer
    MID-ATLANTIC DIAGNOSTICS, INC.
    Date Cleared
    2004-09-29

    (124 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MID-ATLANTIC DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The transfer of the removed blastomere from a holding vessel to a transport vessel. This device is NOT intended for blastomere biopsy from an embryo.
    Device Description
    Stripper PGD® Micropipette and associated tip
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    K Number
    K030525
    Device Name
    CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
    Manufacturer
    MID-ATLANTIC DIAGNOSTICS, INC.
    Date Cleared
    2003-08-27

    (189 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MID-ATLANTIC DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mid-Atlantic Diagnostics Custom Products IVF Workstation is a laminar flow hood that is indicated for use as an accessory to assisted reproduction technologies/in vitro fertilization (ART/IVF) procedures.
    Device Description
    The Mid-Atlantic Diagnostics Custom Products IVF Workstation is a laminar flow hood.
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    K Number
    K993699
    Device Name
    THE STRIPPER
    Manufacturer
    MID-ATLANTIC DIAGNOSTICS, INC.
    Date Cleared
    2000-05-16

    (196 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MID-ATLANTIC DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "THE STRIPPER®" MICROPIPET FAMILY'S INDICATION FOR USE IS T0 MANIPULATE AND TRANSFER ZYGOTES AND EMBRYOS DURING IVF AND ICSI PROCEDURES. "THE STRIPPER®" MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION. "THE STRIPPER®" MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY. REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF. REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES. USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.
    Device Description
    "THE STRIPPER®" micropipetter is a hand held device used to create the vacuum necessary for "THE STRIPPER®" micropipetter tips to aspirate and dispense fluid and cellular material. Its' components include an aluminum barrel that houses a stainless steel plunger and spring, an aluminum plunger shaft with finger pad, o-rings, washer and collet for securing "THE STRIPPER®" tips. "THE STRIPPER®" micropipette tips are fabricated from polycarbonate tubing wherein one end of the tube is pulled to a much smaller dimension to produce tips of varying internal dimensions.
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