K003142 is an FDA 510(k) clearance for the MICROMANIPULATOR. This device is classified as a Micromanipulators And Microinjectors, Assisted Reproduction (Class II - Special Controls, product code MQJ).
Submitted by Research Instruments , Ltd. (Penryn, Corwall, GB). The FDA issued a Cleared decision on November 22, 2000, 43 days after receiving the submission on October 10, 2000.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6150.
| 510(k) Number | K003142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2000 |
| Decision Date | November 22, 2000 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQJ — Micromanipulators And Microinjectors, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6150 |