K914123 is an FDA 510(k) clearance for the SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS, a Dialyzer Reprocessing System (Class II — Special Controls, product code LIF), submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on April 9, 1992, 209 days after receiving the submission on September 13, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K914123 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 13, 1991 |
| Decision Date | April 09, 1992 |
| 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 |