K050026 is an FDA 510(k) clearance for the PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 31, 2005, 25 days after receiving the submission on January 6, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K050026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2005 |
| Decision Date | January 31, 2005 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |