Product code JII— Clinical Toxicology
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
- Classification name
- Atomic Absorption, Lithium
- Device class
- Class 2
- Regulation
- 21 CFR 862.3560
- Advisory panel
- Clinical Toxicology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code JII
FDA has cleared devices under product code JII between 1991 and 2008, filed by 3 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
- 2008
- 2003
- 1991
Top applicants under product code JII
Recent clearances under product code JII
Data sourced from openFDA. This site is unofficial and independent of the FDA.