K033548 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 24, 2003, 12 days after receiving the submission on November 12, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K033548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2003 |
| Decision Date | November 24, 2003 |
| Days to Decision | 12 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KHE — Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |