K133257 is an FDA 510(k) clearance for the BIOPSY PIPETTES. This device is classified as a Microtools, Assisted Reproduction (pipettes) (Class II - Special Controls, product code MQH).
Submitted by Research Instruments , Ltd. (Cornwall, GB). The FDA issued a Cleared decision on May 16, 2014, 205 days after receiving the submission on October 23, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6130.
| 510(k) Number | K133257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2013 |
| Decision Date | May 16, 2014 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQH — Microtools, Assisted Reproduction (pipettes) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6130 |