KQP · Class II · 21 CFR 862.1315

FDA Product Code KQP: Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase

Leading manufacturers include Bio-Rad and Alpkem Corp..

7
Total
7
Cleared
186d
Avg days
1990
Since

FDA 510(k) Cleared Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase Devices (Product Code KQP)

7 devices
1–7 of 7
Cleared Nov 04, 1999
BIO-RAD CODA NEONATAL GALT ASSAY
K993536
Bio-Rad
Chemistry · 16d
Cleared Apr 09, 1999
MICROPLATE NEONATAL GALT ASSAY
K990827
Bio-Rad
Chemistry · 28d
Cleared Jan 11, 1990
TOTAL GALACTOSE
K894011
Alpkem Corp.
Chemistry · 219d

About Product Code KQP - Regulatory Context