ADVIA IMS LITHIUM ASSAY
FDA 510(k) clearance K050374 · decided 2005-06-15
Clearance details
- K-number
- K050374
- Device name
- ADVIA IMS LITHIUM ASSAY
- Applicant
- Bayer Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-02-14
- Decision date
- 2005-06-15
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- NDW
- Device class
- 2
- Regulation number
- 862.3560
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Tarrytown, NY, 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 |
| LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (K003583) | Trace America, Inc. | 2001-01-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assa recall (Z-0104-2023) | Siemens Healthcare Diagnostics, Inc. | 2022-10-20 |
| Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay recall (Z-0105-2023) | Siemens Healthcare Diagnostics, Inc. | 2022-10-20 |
| Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagen recall (Z-0365-2014) | Siemens Healthcare Diagnostics | 2013-11-19 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018) | Bayer Healthcare, LLC | 2004-12-22 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001) | Bayer Healthcare, LLC | 1995-12-13 |