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

K142991 is an FDA 510(k) premarket notification submitted by Life Global Group, LLC for the device "LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA". The FDA issued a decision of Substantially Equivalent on February 17, 2015. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Life Global Group, LLC has at least 2 other 510(k) clearances on record.

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