K232493 is an FDA 510(k) clearance for the Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004). This device is classified as a Accessory, Assisted Reproduction (Class II - Special Controls, product code MQG).
Submitted by Wuhan Huchuang Union Technology Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on May 7, 2024, 264 days after receiving the submission on August 17, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6120.
| 510(k) Number | K232493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2023 |
| Decision Date | May 07, 2024 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQG - Accessory, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6120 |