K974798 is an FDA 510(k) clearance for the STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS. This device is classified as a Dialyzer Reprocessing System (Class II - Special Controls, product code LIF).
Submitted by Environmental Test Systems, Inc. (Elkhart, US). The FDA issued a Cleared decision on March 20, 1998, 88 days after receiving the submission on December 22, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K974798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1997 |
| Decision Date | March 20, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LIF — Dialyzer Reprocessing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |