510(k) K103028
K103028 is an FDA 510(k) premarket notification submitted by Auxogyn, Inc. for the device "EEVATM PETRI DISH". The FDA issued a decision of Substantially Equivalent on August 11, 2011. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Auxogyn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2011
- Date Received
- October 13, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Labware, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6160
- Review Panel
- OB
- Submission Type