K133707 is an FDA 510(k) clearance for the SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Origio A/S (Måløv, DK). The FDA issued a Cleared decision on April 16, 2014, 133 days after receiving the submission on December 4, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K133707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2013 |
| Decision Date | April 16, 2014 |
| Days to Decision | 133 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 |