K040660 is an FDA 510(k) clearance for the STERICHEK GLUTARALDEHYDE REAGENT STRIPS. This device is classified as a Dialyzer Reprocessing System (Class II - Special Controls, product code LIF).
Submitted by Hach Company (Elkhart, US). The FDA issued a Cleared decision on November 15, 2004, 248 days after receiving the submission on March 12, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K040660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2004 |
| Decision Date | November 15, 2004 |
| Days to Decision | 248 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 |