510(k) K063684
- Device
- COBAS LITHIUM
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K063684
- Product code
- NDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-21
- Date received
- 2006-12-12
- Regulation
- 862.3560
- Classification name
- Assay, Porphyrin, Spectrophotometry, Lithium
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THERESA AMBROSE BUSH
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3002809144
- 9610529
- 2517506
- 9681753
- 9610126
- 3005333358
- 3006198300
- 3003795116
- 2432235
- 1181121
Source Documents#
Other 510(k) Records For Product Code NDW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243462 | Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. | 2025-08-01 |
| K112142 | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2011-11-04 |
| K063705 | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL | Thermo Electron OY | 2007-10-09 |
| K070987 | SENTINEL LITHIUM ASSAY | SENTINEL CH. SpA | 2007-08-02 |
| K050374 | ADVIA IMS LITHIUM ASSAY | Bayer Healthcare, LLC | 2005-06-15 |
| K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | Trace America, Inc. | 2001-01-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary