Submission Details
| 510(k) Number | K063145 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 16, 2006 |
| Decision Date | October 17, 2007 |
| Days to Decision | 366 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
Oct 2007
Decision
366d
Days
Class 2
Risk
About This 510(k) Submission
K063145 is an FDA 510(k) clearance for the PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on October 17, 2007, 366 days after receiving the submission on October 16, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.
Device Classification
| Product Code | DIP — Enzyme Immunoassay, Diphenylhydantoin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3350 |
Manufacturer
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