K874034 is an FDA 510(k) clearance for the ADR-22 AUTOMATIC DIALYZER REPROCESSOR. This device is classified as a Dialyzer Reprocessing System (Class II - Special Controls, product code LIF).
Submitted by Biodynamics Corp. (Houston, US). The FDA issued a Cleared decision on October 23, 1987, 18 days after receiving the submission on October 5, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K874034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1987 |
| Decision Date | October 23, 1987 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LIF — Dialyzer Reprocessing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |