LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA— 510(k) K142991
Substantially EquivalentLife Global Group, LLC
FDA 510(k) clearance K142991 for LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA, Substantially Equivalent on 2015-02-17. Applicant: Life Global Group, LLC. Device class: 2.
Clearance details
- Applicant
- Life Global Group, LLC
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gilford, CT, US
Recent devices under product code MQL
view allMore clearances from Life Global Group, LLC
view allRecalls naming K142991
K-number listed on FDA's recall record- Z-1089-2024 — global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
- Z-1348-2023 — Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142991.
Data sourced from openFDA. This site is unofficial and independent of the FDA.