K123805 is an FDA 510(k) clearance for the E-Z CHEK BLOOD LEAK TEST STRIPS. This device is classified as a Detector, Leak, Blood (Class II - Special Controls, product code FJD).
Submitted by Reprocessing Products Corp (Tucson, US). The FDA issued a Cleared decision on March 20, 2013, 99 days after receiving the submission on December 11, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K123805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2012 |
| Decision Date | March 20, 2013 |
| Days to Decision | 99 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 |