Panels › Clinical Toxicology › Product code DNN · Class 2
Calibrators, Ethyl Alcohol
Regulation 862.3200
0510(k)s in 12 months (7 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in DNN
| Company | 510(k)s | Recalls |
|---|---|---|
| Emd Chemicals, Inc. | 2 | 1 |
| Syva Co. | 2 | 0 |
| Diagnostic Reagents, Inc. | 1 | 0 |
| Diagnostic Systems | 1 | 0 |
| Hospira, Inc. | 0 | 1 |
| Verichem Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2010 | Hospira, Inc. EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5 Terminated |
DNN | None listed |
| Sep 16, 2008 | EMD Chemicals Inc EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml;
1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic. Terminated |
DNN | K990516 |
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