HIO · Class I · 21 CFR 884.1550

FDA Product Code HIO: Sampler, Amniotic Fluid (amniocentesis Tray)

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic and Baxter Healthcare Corp.

20
Total
20
Cleared
113d
Avg days
1976
Since

FDA 510(k) Cleared Sampler, Amniotic Fluid (amniocentesis Tray) Devices (Product Code HIO)

20 devices
1–20 of 20
Cleared Aug 04, 1989
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031
Baxter Healthcare Corp
Obstetrics & Gynecology · 59d
Cleared Mar 17, 1986
HURWITZ AMNIOCENTESIS NEEDLE
K854725
Bd Becton Dickinson Vacutainer Systems Preanalytic
Obstetrics & Gynecology · 115d

About Product Code HIO - Regulatory Context