K911629 is an FDA 510(k) clearance for the SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%). This device is classified as 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 June 27, 1991, 77 days after receiving the submission on April 11, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K911629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1991 |
| Decision Date | June 27, 1991 |
| Days to Decision | 77 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 |