K033462 is an FDA 510(k) clearance for the EARLY CLEAVAGE MEDIUM (ECM), a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 15, 2004, 76 days after receiving the submission on October 31, 2003. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K033462 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 2003 |
| Decision Date | January 15, 2004 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6180 |