K041812 is an FDA 510(k) clearance for the MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC). This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 27, 2004, 21 days after receiving the submission on July 6, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K041812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2004 |
| Decision Date | July 27, 2004 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |