K992016 is an FDA 510(k) clearance for the AMUKIN D. This device is classified as a Dialyzer Reprocessing System (Class II - Special Controls, product code LIF).
Submitted by Amuchina Intl., Inc. (Gaithersburg, US). The FDA issued a Cleared decision on January 10, 2000, 209 days after receiving the submission on June 15, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K992016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1999 |
| Decision Date | January 10, 2000 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LIF — Dialyzer Reprocessing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |