Panels › Clinical Toxicology › Product code QDR · Class 2
Plazomicin Test System, Immunoassay
Regulation 862.3460
0510(k)s in 12 months (1 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in QDR
| Company | 510(k)s | Recalls |
|---|---|---|
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Microgenics Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2018 | DEN180030 | QMS Plazomicin Immunoassay Microgenics Corporation | QDR |
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