K852359 is an FDA 510(k) clearance for the AMUCHINA/DIALYZER DISINFECTANT. This device is classified as a System, Dialysate Delivery, Central Multiple Patient (Class II - Special Controls, product code FKQ).
Submitted by Amuchina Intl., Inc. (Washington, US). The FDA issued a Cleared decision on May 13, 1986, 343 days after receiving the submission on June 4, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K852359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1985 |
| Decision Date | May 13, 1986 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKQ — System, Dialysate Delivery, Central Multiple Patient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |