K151578 is an FDA 510(k) clearance for the Carbamazepine Gen 4. This device is classified as a Enzyme Immunoassay, Carbamazepine (Class II - Special Controls, product code KLT).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on October 22, 2015, 133 days after receiving the submission on June 11, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K151578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2015 |
| Decision Date | October 22, 2015 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | KLT — Enzyme Immunoassay, Carbamazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3645 |