K090429 is an FDA 510(k) clearance for the NUNC IVF CENTERWELL AND ICSI DISHES. This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Thermo Fisher Scientific (Nalge Nunc Intl) (Rochester, US). The FDA issued a Cleared decision on September 18, 2009, 211 days after receiving the submission on February 19, 2009.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K090429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2009 |
| Decision Date | September 18, 2009 |
| Days to Decision | 211 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 |