JIA · Class I · 21 CFR 862.1310

FDA Product Code JIA: Enzymatic Methods, Galactose

Leading manufacturers include Isolab, Inc., Icn Pharmaceuticals, Inc. and Wallac OY.

9
Total
9
Cleared
237d
Avg days
1995
Since

FDA 510(k) Cleared Enzymatic Methods, Galactose Devices (Product Code JIA)

9 devices
1–9 of 9
Cleared Nov 06, 2019
GSP Neonatal Total Galactose kit
K190335
Perkinelmer, Inc.
Chemistry · 265d
Cleared Aug 07, 2008
NEONATAL TOTAL GALACTOSE KIT
K071649
Wallac OY
Chemistry · 416d
Cleared Feb 01, 1996
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
K950481
Isolab, Inc.
Chemistry · 363d
Cleared Nov 09, 1995
IMMUCHEM GAL-MW EA
K951329
Icn Pharmaceuticals, Inc.
Chemistry · 231d

About Product Code JIA - Regulatory Context