Product code LFO— Clinical Toxicology
DART PHENYTOIN
- Classification name
- Nephelometric Inhibition Immunoassay, Diphenylhydantoin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LFO
FDA has cleared device under product code LFO, all in 1988, filed by 1 applicant company. 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.
Top applicants under product code LFO
Recent clearances under product code LFO
Data sourced from openFDA. This site is unofficial and independent of the FDA.