K042322 is an FDA 510(k) clearance for the STERICHEK BLOOD LEAK REAGENT STRIPS. This device is classified as a Detector, Leak, Blood (Class II - Special Controls, product code FJD).
Submitted by Hach Company (Elkhart, US). The FDA issued a Cleared decision on December 7, 2004, 103 days after receiving the submission on August 26, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K042322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2004 |
| Decision Date | December 07, 2004 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJD — Detector, Leak, Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |