HIO

Sampler, Amniotic Fluid (Amniocentesis Tray)

Product code: HIO
Device name: Sampler, Amniotic Fluid (Amniocentesis Tray)
Device class: Class 1
21 CFR: 21 CFR 884.1550
Medical specialty: Obstetrics/Gynecology
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 20 (all years; only the last 3 years are listed here)

Official FDA classification page: HIO

Classification and pathway per current FDA publications. Data from openFDA (CC0).