K082811 is an FDA 510(k) clearance for the URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS. This device is classified as a Blood, Occult, Colorimetric, In Urine (Class II - Special Controls, product code JIO).
Submitted by Urit Medical Electronic Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 11, 2009, 352 days after receiving the submission on September 24, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K082811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2008 |
| Decision Date | September 11, 2009 |
| Days to Decision | 352 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIO - Blood, Occult, Colorimetric, In Urine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |