Product code LCY— Clinical Toxicology
GDS ENZYMATIC THEOPHYLLINE REAGENT
- Classification name
- U.V. Spectrometry, Theophylline
- Device class
- Class 2
- Regulation
- 21 CFR 862.3880
- Advisory panel
- Clinical Toxicology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code LCY
FDA has cleared devices under product code LCY between 1978 and 1989, filed by 2 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
- 1989
- 1978
Top applicants under product code LCY
Recent clearances under product code LCY
Data sourced from openFDA. This site is unofficial and independent of the FDA.