K171224 is an FDA 510(k) clearance for the Arctic Sperm Cryopreservation Medium. This device is classified as 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 August 31, 2017, 127 days after receiving the submission on April 26, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K171224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2017 |
| Decision Date | August 31, 2017 |
| Days to Decision | 127 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 |