K032332 is an FDA 510(k) clearance for the ROCHE ONLINE TDM QUINIDINE. This device is classified as a Enzyme Immunoassay, Quinidine (Class II - Special Controls, product code LBZ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 12, 2004, 167 days after receiving the submission on July 29, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K032332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2003 |
| Decision Date | January 12, 2004 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LBZ — Enzyme Immunoassay, Quinidine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |