Product code NDW— Clinical Toxicology
ADVIA IMS LITHIUM ASSAY
- Classification name
- Assay, Porphyrin, Spectrophotometry, Lithium
- Device class
- Class 2
- Regulation
- 21 CFR 862.3560
- Advisory panel
- Clinical Toxicology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code NDW
FDA has cleared devices under product code NDW between 2001 and 2025, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2011
- 2008
- 2007
- 2005
- 2001
Top applicants under product code NDW
Recent clearances under product code NDW
- K243462 — Diazyme Colorimetric Lithium Assay
- K112142 — DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
- K063684 — COBAS LITHIUM
- K063705 — LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
- K070987 — SENTINEL LITHIUM ASSAY
- K050374 — ADVIA IMS LITHIUM ASSAY
- K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
Data sourced from openFDA. This site is unofficial and independent of the FDA.