Product code MOJ— Clinical Toxicology
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
- Classification name
- Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code MOJ
FDA has cleared devices under product code MOJ between 1995 and 2023, 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
- 2023
- 1995
Top applicants under product code MOJ
Recent clearances under product code MOJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.