KQPClass II
Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Clinical Chemistry · 21 CFR 862.1315
MDR events0All time
Recalls1All time
Registered firms6Currently listed
510(k) clearances7All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
6 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Astoria-Pacific, Inc.Jul 15, 2011
K102643 · SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
- Astoria-Pacific, Inc.Feb 4, 2011
K101392 · NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
- Perkinelmer, Inc.Jun 11, 2010
K100101 · GSP NEONATALGALT KIT, MODEL 3303-001U
- Bio-RadNov 4, 1999
K993536 · BIO-RAD CODA NEONATAL GALT ASSAY
- Bio-RadApr 9, 1999
K990827 · MICROPLATE NEONATAL GALT ASSAY
- Astoria-Pacific, Inc.Dec 11, 1997
K970277 · URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
- Alpkem Corp.Jan 11, 1990
K894011 · TOTAL GALACTOSE