Panels › Clinical Chemistry › Product code JIA · Class 1
Enzymatic Methods, Galactose
Regulation 862.1310
0510(k)s in 12 months (9 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in JIA
| Company | 510(k)s | Recalls |
|---|---|---|
| PerkinElmer Life Sciences Inc | 0 | 3 |
| Perkin Elmer Life and Analytical Sciences Inc | 0 | 2 |
| Quantase , Ltd. | 2 | 0 |
| Astoria-Pacific, Inc. | 1 | 0 |
| Icn Pharmaceuticals, Inc. | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Neometrics, Inc. | 1 | 0 |
| Perkinelmer, Inc. | 1 | 0 |
| PerkinElmer LAS Inc | 0 | 1 |
| Wallac OY | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2004 | PerkinElmer LAS Inc Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000. Terminated |
JIA | None listed |
| Jul 20, 2004 | Perkin Elmer Life and Analytical Sciences Inc Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000 Terminated |
JIA | K950481 |
| Jul 20, 2004 | Perkin Elmer Life and Analytical Sciences Inc Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000 Terminated |
JIA | K950481 |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays. Terminated |
JIA | K950481 |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays. Terminated |
JIA | K950481 |
| Jul 2, 2003 | PerkinElmer Life Sciences Inc Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays. Terminated |
JIA | K950481 |
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