LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
FDA 510(k) clearance K003583 · decided 2001-01-17
Clearance details
- K-number
- K003583
- Device name
- LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
- Applicant
- Trace America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-20
- Decision date
- 2001-01-17
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- NDW
- Device class
- 2
- Regulation number
- 862.3560
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Arlington, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Diazyme Colorimetric Lithium Assay (K243462) | Diazyme Laboratories, Inc. | 2025-08-01 |
| DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE (K112142) | Siemens Healthcare Diagnostics | 2011-11-04 |
| COBAS LITHIUM (K063684) | Roche Diagnostics Corp. | 2008-03-21 |
| LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL (K063705) | Thermo Electron OY | 2007-10-09 |
| SENTINEL LITHIUM ASSAY (K070987) | SENTINEL CH. SpA | 2007-08-02 |
| ADVIA IMS LITHIUM ASSAY (K050374) | Bayer Healthcare, LLC | 2005-06-15 |
Recalls involving this device
No recalls on record reference this clearance.