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510(k) K142991

LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA by Life Global Group, LLC — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2015
Date Received
October 16, 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)
  • K143498 — LifeGlobal Global HP (January 20, 2015)

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  • K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); (March 21, 2025)
  • K241833 — V-GRAD (March 21, 2025)
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