K142991 is an FDA 510(k) clearance for the LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Life Global Group, LLC (Gilford, US). The FDA issued a Cleared decision on February 17, 2015, 124 days after receiving the submission on October 16, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K142991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2014 |
| Decision Date | February 17, 2015 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |