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510(k) K143498

LifeGlobal Global HP by Life Global Group, LLC — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2015
Date Received
December 10, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by Life Global Group, LLC

  • K152581 — LifeGlobal Micro Tips (April 11, 2016)
  • K142991 — LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, (February 17, 2015)

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  • K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (April 10, 2025)
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  • K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); (March 21, 2025)
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