510(k) K092578

LIFEGLOBAL PROTEIN SUPPLEMENT by Genx Intl., Inc. — Product Code MQL

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