510(k) K092578
K092578 is an FDA 510(k) premarket notification submitted by Genx Intl., Inc. for the device "LIFEGLOBAL PROTEIN SUPPLEMENT". The FDA issued a decision of Substantially Equivalent on April 5, 2010. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Genx Intl., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2010
- Date Received
- August 21, 2009
- 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