Submission Details
| 510(k) Number | K063705 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 13, 2006 |
| Decision Date | October 09, 2007 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
Oct 2007
Decision
300d
Days
Class 2
Risk
About This 510(k) Submission
K063705 is an FDA 510(k) clearance for the LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL, a Assay, Porphyrin, Spectrophotometry, Lithium (Class II — Special Controls, product code NDW), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on October 9, 2007, 300 days after receiving the submission on December 13, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3560.
Device Classification
| Product Code | NDW — Assay, Porphyrin, Spectrophotometry, Lithium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3560 |
Manufacturer
Similar Devices — NDW Assay, Porphyrin, Spectrophotometry, Lithium
K243462 · Diazyme Laboratories, Inc.
· Aug 2025
K112142 · Siemens Healthcare Diagnostics
· Nov 2011
K063684 · Roche Diagnostics Corp.
· Mar 2008
K070987 · SENTINEL CH. SpA
· Aug 2007
K050374 · Bayer Healthcare, LLC
· Jun 2005
K003583 · Trace America, Inc.
· Jan 2001
More from Thermo Electron OY
View all
K063145
· DIP · Oct 2007
K063131
· KLT · Oct 2007
K063838
· DFC · Sep 2007
K063086
· DDG · Aug 2007
K063209
· LCP · Mar 2007