Panels › Clinical Toxicology › Product code LER · Class 2
Fluorescent Immunoassay, Theophylline
Regulation 862.3880
0510(k)s in 12 months (15 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LER
| Company | 510(k)s | Recalls |
|---|---|---|
| Miles Laboratories, Inc. | 3 | 0 |
| 3M Company | 1 | 0 |
| Abbott Diagnostic International, Ltd. | 0 | 1 |
| Abbott Laboratories | 1 | 0 |
| American Diagnostic Corp. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Hoffmann-La Roche, Inc. | 1 | 0 |
| Microgenics Corp. | 1 | 0 |
| Paragon Diagnostics, Inc. | 1 | 0 |
| Sclavo, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2007 | Abbott Diagnostic International, Ltd. IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test.
This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) Terminated |
LER | K833070 |
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