LGS

Fluorescence Polarization Immunoassay, Theophylline

Product code
LGS
Device name
Fluorescence Polarization Immunoassay, Theophylline
Device class
Class 2
21 CFR
21 CFR 862.3880
Medical specialty
Clinical Toxicology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (all years, FDA)
13 (all years; only the last 3 years are listed here)
Official FDA classification page: LGS
Classification and pathway per current FDA publications. Data from openFDA (CC0).