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Found 8 results
510(k) Data Aggregation
K Number
K030850Device Name
ENHANCE HUMAN SERUM ALBUMIN
Manufacturer
CONCEPTION TECHNOLOGIES
Date Cleared
2003-04-08
(22 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
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
K023655Device Name
ENHANCE HTF MEDIUM WITH HEPES
Manufacturer
CONCEPTION TECHNOLOGIES
Date Cleared
2002-12-13
(44 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
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
K023717Device Name
SPERM WASH MEDIUM WITH GENTAMICIN
Manufacturer
CONCEPTION TECHNOLOGIES
Date Cleared
2002-12-13
(38 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
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
K020490Device Name
PBS, PBSW WITH CATIONS AND PHENOL RED
Manufacturer
CONCEPTION TECHNOLOGIES
Date Cleared
2002-03-28
(43 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
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
K011481Device Name
10% PVP; 10% PVP IN EBSS SOLUTION
Manufacturer
CONCEPTION TECHNOLOGIES
Date Cleared
2001-07-02
(49 days)
Product Code
MQL
Regulation Number
884.6180Why 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
K011573Device Name
HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
Manufacturer
CONCEPTION TECHNOLOGIES
Date Cleared
2001-07-02
(42 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
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
K011462Device Name
OIL FOR TISSUE CULTURE
Manufacturer
CONCEPTION TECHNOLOGIES
Date Cleared
2001-06-13
(30 days)
Product Code
MQL
Regulation Number
884.6180Why 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
K993140Device Name
WATER FOR TISSUE CULTURE, MODELS 1500
Manufacturer
CONCEPTION TECHNOLOGIES
Date Cleared
2000-08-02
(317 days)
Product Code
MTW
Regulation Number
884.6170Why did this record match?
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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