| Device |
turbidimetric method, protein or albumin (urinary, non-quant.) |
| Regulation Description |
Urinary protein or albumin (nonquantitative) test system. |
| Product Code | JIQ |
| Regulation Number |
862.1645
|
| Device Class |
1
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
|
| Recalls |
| Manufacturer |
Recall Class |
Date Posted |
| 1 |
HemoCue AB |
III |
Dec-28-2012 |
|
|
|