KQP · Class II · 21 CFR 862.1315

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

Leading manufacturers include Astoria-Pacific, Inc., Bio-Rad and Perkinelmer, Inc..

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 Jul 15, 2011
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
K102643
Astoria-Pacific, Inc.
Chemistry · 304d
Cleared Feb 04, 2011
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
K101392
Astoria-Pacific, Inc.
Chemistry · 262d
Cleared Jun 11, 2010
GSP NEONATALGALT KIT, MODEL 3303-001U
K100101
Perkinelmer, Inc.
Chemistry · 149d
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 Dec 11, 1997
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
K970277
Astoria-Pacific, Inc.
Chemistry · 322d
Cleared Jan 11, 1990
TOTAL GALACTOSE
K894011
Alpkem Corp.
Chemistry · 219d

About Product Code KQP - Regulatory Context