K123518 is an FDA 510(k) clearance for the ABBOTT CARBAMAZEPINE ASSAY. This device is classified as a Enzyme Immunoassay, Carbamazepine (Class II - Special Controls, product code KLT).
Submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on June 5, 2013, 203 days after receiving the submission on November 14, 2012.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K123518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2012 |
| Decision Date | June 05, 2013 |
| Days to Decision | 203 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 |