510(k) K141663
K141663 is an FDA 510(k) premarket notification submitted by Auxogyn, Inc. for the device "EEVA DISH (WITH 12 MICROWELLS)". The FDA issued a decision of Substantially Equivalent on July 22, 2014. 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
- July 22, 2014
- Date Received
- June 23, 2014
- Clearance Type
- Special
- 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