K103627 is an FDA 510(k) clearance for the ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS. This device is classified as a Enzyme Immunoassay, Carbamazepine (Class II - Special Controls, product code KLT).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 14, 2011, 305 days after receiving the submission on December 13, 2010.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K103627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2010 |
| Decision Date | October 14, 2011 |
| Days to Decision | 305 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 |