LifeGlobal Protein Supplement
by <Genx> Intl., Inc. 510(k)
Active
510(k) K092578
Overview
LifeGlobal Protein Supplement is a device used in assisted reproductive procedures that require protein supplementation. It is intended for use in procedures such as in vitro fertilization, embryo culture and growth, and embryo cryopreservation.
The device is supplied as a protein supplement for use in clinical settings supporting reproductive medicine. It is classified as a Class II medical device under FDA regulation number 884.6180 and was cleared via the traditional 510(k) pathway (K092578) on April 5, 2010, with substantial equivalence established.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092578 | Date5 Apr 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MQL
- FDA applicant
- Genx Intl., Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent