FDA 510(k) Applications for Medical Device Product Code "KQP"
(Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase)

FDA 510(k) Number Applicant Device Name Decision Date
K101392 ASTORIA-PACIFIC,INC. NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D 02/04/2011
K102643 ASTORIA-PACIFIC,INC. SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT 07/15/2011
K970277 ASTORIA-PACIFIC,INC. URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) 12/11/1997
K993536 BIO-RAD BIO-RAD CODA NEONATAL GALT ASSAY 11/04/1999
K990827 BIO-RAD MICROPLATE NEONATAL GALT ASSAY 04/09/1999
K100101 PERKINELMER, INC. GSP NEONATALGALT KIT, MODEL 3303-001U 06/11/2010


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