DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
FDA 510(k) clearance K112142 · decided 2011-11-04
Clearance details
- K-number
- K112142
- Device name
- DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2011-07-26
- Decision date
- 2011-11-04
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- NDW
- Device class
- 2
- Regulation number
- 862.3560
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Siemens Healthcare Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (K003583) | Trace America, Inc. | 2001-01-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vit recall (Z-1151-2013) | Siemens Healthcare Diagnostics, Inc. | 2013-04-18 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024) | Siemens Healthcare Diagnostics | 2025-10-17 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013) | Siemens Healthcare Diagnostics | 2025-10-17 |
| ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030) | Siemens Healthcare Diagnostics | 2025-07-16 |
| ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029) | Siemens Healthcare Diagnostics | 2025-07-16 |
| Dimension TPSA Flex reagent cartridge (P000021/S047) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S042) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
| Dimension TPSA Flex reagent cartridge (P000021/S046) | Siemens Healthcare Diagnostics | 2025-02-24 |