K103028 is an FDA 510(k) clearance for the EEVATM PETRI DISH, a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Auxogyn, Inc. (Menlo Park, US). The FDA issued a Cleared decision on August 11, 2011, 302 days after receiving the submission on October 13, 2010. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K103028 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 13, 2010 |
| Decision Date | August 11, 2011 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQK — Labware, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6160 |