JIA · Class I · 21 CFR 862.1310

FDA Product Code JIA: Enzymatic Methods, Galactose

Leading manufacturers include Quantase , Ltd., Wallac OY and Astoria-Pacific, Inc..

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 Apr 28, 2014
GSP NEONATAL TOTAL GALACTOSE KIT
K133652
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Chemistry · 152d
Cleared Jun 20, 2013
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
K121101
Astoria-Pacific, Inc.
Chemistry · 435d
Cleared Aug 07, 2008
NEONATAL TOTAL GALACTOSE KIT
K071649
Wallac OY
Chemistry · 416d
Cleared Jun 21, 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY
K990644
Quantase , Ltd.
Chemistry · 115d
Cleared Jun 21, 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
K990654
Quantase , Ltd.
Chemistry · 112d
Cleared Jun 16, 1999
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
K991498
Neometrics, Inc.
Chemistry · 48d
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