Panels › Clinical Chemistry › Product code KQP · Class 2
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Regulation 862.1315
0510(k)s in 12 months (7 all time)
1recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in KQP
| Company | 510(k)s | Recalls |
|---|---|---|
| Astoria-Pacific, Inc. | 3 | 0 |
| Bio-Rad | 2 | 0 |
| Alpkem Corp. | 1 | 0 |
| Perkinelmer, Inc. | 1 | 0 |
| WALLAC OY | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2011 | K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT Astoria-Pacific, Inc. | KQP |
| Feb 4, 2011 | K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D Astoria-Pacific, Inc. | KQP |
| Jun 11, 2010 | K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U Perkinelmer, Inc. | KQP |
| Nov 4, 1999 | K993536 | BIO-RAD CODA NEONATAL GALT ASSAY Bio-Rad | KQP |
| Apr 9, 1999 | K990827 | MICROPLATE NEONATAL GALT ASSAY Bio-Rad | KQP |
| Dec 11, 1997 | K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) Astoria-Pacific, Inc. | KQP |
| Jan 11, 1990 | K894011 | TOTAL GALACTOSE Alpkem Corp. | KQP |
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