LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
FDA 510(k) clearance K142991 · decided 2015-02-17
Clearance details
- K-number
- K142991
- Device name
- LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
- Applicant
- Life Global Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-10-16
- Decision date
- 2015-02-17
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Gilford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100 recall (Z-1089-2024) | CooperSurgical, Inc. | 2024-02-14 |
| Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo cultu recall (Z-1348-2023) | CooperSurgical, Inc. | 2023-04-06 |