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510(k) Data Aggregation
K Number
K011598Device Name
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
Manufacturer
IRVINE SCIENTIFIC SALES CO., INC.
Date Cleared
2001-06-13
(20 days)
Product Code
MTW
Regulation Number
884.6170Why did this record match?
Product Code :
MTW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water.
Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures.
Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in assisted reproductive technology procedures.
Device Description
Water for Assisted Reproductive Technologies (A.R.T.) Use is a water intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water.
Water for Assisted Reproductive Technologies (A.R.T.) Use is highly purified water of USP WFI grade.
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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?
Product Code :
MTW
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
Not Found
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