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510(k) Data Aggregation
K Number
K991381Device Name
PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA
Manufacturer
Date Cleared
1999-09-24
(156 days)
Product Code
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
PACIFIC ANDROLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.
Device Description
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K Number
K991388Device Name
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
Manufacturer
Date Cleared
1999-09-13
(145 days)
Product Code
Regulation Number
884.6130Why did this record match?
Applicant Name (Manufacturer) :
PACIFIC ANDROLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Pacific Andrology, Inc. Microtools are a family of precision pipettes that are used for assisted reproduction procedures. They are designed, for use to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction methods.
ICSI micropipettes are used for the intracytoplasmic single sperm injection of oocytes.
Assisted hatching micropipettes are used to effect a hole in the zona pellucida by chemical means.
The Holding Micropipettes are used to hold the oocyte in position during single sperm injection with the Intracytoplasmic sperm injection (ICSI) Micropipette, to hold the embryo during the assisted hatching or during partial zona dissection procedures.
Partial zona dissection micropipettes are used to facilitate assisted hatching by mechanically creating a hole in the zona pellucida.
The Denuding Pipettes are used to remove cumulus cell layers from oocytes.
Device Description
Microtools are a family of precision pipettes.
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