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510(k) Data Aggregation
K Number
K152581Device Name
LifeGlobal Micro Tips
Manufacturer
LifeGlobal Group, LLC
Date Cleared
2016-04-11
(214 days)
Product Code
MQH
Regulation Number
884.6130Why did this record match?
Applicant Name (Manufacturer) :
LifeGlobal Group, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InteGlobal MicroTips TPLG-130 are used for Denuding, handling blastomeres, oocytes and oocyte stripping. LifeGlobal MicroTips TPLG-180, TPLG-225 and TPLG-275 are used for handling embryos and blastocysts.
Device Description
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K Number
K142991Device Name
LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
Manufacturer
LifeGlobal Group, LLC
Date Cleared
2015-02-17
(124 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
LifeGlobal Group, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LifeGlobal® Global® Total® w/HSA: Culture of embryos from zygote to blastocyst, embryo transfer
LifeGlobal® Global® Total® for Fertilization w/HSA: Oocyte culture and fertilization
LifeGlobal® Global® Total® w/HEPES w/HSA: Oocyte and embryo washing, manipulation, fertilization by intracytoplasmic sperm injection (ICSI), embryo transfer
Device Description
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K Number
K143498Device Name
LifeGlobal Global HP
Manufacturer
LifeGlobal Group, LLC
Date Cleared
2015-01-20
(41 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
LifeGlobal Group, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Culture of human embryos from zygote to blastocyst, embryo transfer.
Device Description
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