K060738 is an FDA 510(k) clearance for the TDM N-ACETYLPROCAINAMIDE. This device is classified as a Enzyme Immunoassay, N-acetylprocainamide (Class II - Special Controls, product code LAN).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 16, 2006, 149 days after receiving the submission on March 20, 2006.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K060738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2006 |
| Decision Date | August 16, 2006 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAN — Enzyme Immunoassay, N-acetylprocainamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |