K201213 is an FDA 510(k) clearance for the Pasteur Pipette 3mL, Pasteur Pipette 1mL. This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Hertart Aps (Västra Frölunda, SE). The FDA issued a Cleared decision on December 16, 2020, 225 days after receiving the submission on May 5, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K201213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2020 |
| Decision Date | December 16, 2020 |
| Days to Decision | 225 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 |