Submission Details
| 510(k) Number | K063131 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 13, 2006 |
| Decision Date | October 05, 2007 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
Oct 2007
Decision
357d
Days
Class 2
Risk
About This 510(k) Submission
K063131 is an FDA 510(k) clearance for the CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on October 5, 2007, 357 days after receiving the submission on October 13, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.
Device Classification
| Product Code | KLT — Enzyme Immunoassay, Carbamazepine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3645 |
Manufacturer
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