Cobas Lithium
FDA 510(k) K063684 · Roche Diagnostics Corp.
510(k) numberK063684
Submission
- Device name
- Cobas Lithium
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- December 12, 2006
- Decision date
- March 21, 2008
- 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
Other 510(k)s with product code NDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243462 | Diazyme Colorimetric Lithium AssayNDW · Traditional | Diazyme Laboratories, Inc. | 08/01/2025SE |
| K112142 | Dimension Vista Lithium Flex Reagent CartridgeNDW · Traditional | Siemens Healthcare Diagnostics | 11/04/2011SE |
| K063705 | Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM…NDW · Traditional | Thermo Electron OY | 10/09/2007SE |
| 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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| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Cobas Lithium cleared by the FDA?
Cobas Lithium (K063684) received a 510(k) decision of Substantially Equivalent on March 21, 2008, 465 days after the submission was received.
What is the product code of K063684?
The FDA product code is NDW – Assay, Porphyrin, Spectrophotometry, Lithium, a Class II (moderate risk) device regulated under 21 CFR 862.3560.