K101305 is an FDA 510(k) clearance for the ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL. This device is classified as a Lamotrigine Assay (Class II - Special Controls, product code ORH).
Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 29, 2010, 172 days after receiving the submission on May 10, 2010.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350. For The Quantitative Determination Of Lamotrigine In Human Serum Or Plasma On Automated Clinical Chemistry Analyzers..
| 510(k) Number | K101305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2010 |
| Decision Date | October 29, 2010 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | ORH - Lamotrigine Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |
| Definition | For The Quantitative Determination Of Lamotrigine In Human Serum Or Plasma On Automated Clinical Chemistry Analyzers. |