Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol
FDA 510(k) K063705 · Thermo Electron OY
510(k) numberK063705
Submission
- Device name
- Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol
- Applicant
- Thermo Electron OY
Vantaa, FI - Received
- December 13, 2006
- Decision date
- October 9, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDW – Assay, Porphyrin, Spectrophotometry, Lithium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3560
- Specialty
- Clinical Toxicology
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|---|---|---|---|
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| K063684 | Cobas LithiumNDW · Traditional | Roche Diagnostics Corp. | 03/21/2008SE |
| K070987 | Sentinel Lithium AssayNDW · Traditional | SENTINEL CH. SpA | 08/02/2007SE |
| K050374 | Advia Ims Lithium AssayNDW · Traditional | Bayer Healthcare, LLC | 06/15/2005SE |
| K003583 | Lithium Regent Model TR66056 / Lithium Standard TR66901NDW · Traditional | Trace America, Inc. | 01/17/2001SE |
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Questions and answers
When was Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol cleared by the FDA?
Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol (K063705) received a 510(k) decision of Substantially Equivalent on October 9, 2007, 300 days after the submission was received.
What is the product code of K063705?
The FDA product code is NDW – Assay, Porphyrin, Spectrophotometry, Lithium, a Class II (moderate risk) device regulated under 21 CFR 862.3560.