Panels › Clinical Toxicology › Product code LCQ · Class 2
Fluorescent Immunoassay Gentamicin
Regulation 862.3450
0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in LCQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Diagnostic International, Ltd. | 0 | 2 |
| Abbott Laboratories | 2 | 0 |
| Roche Diagnostic Systems, Inc. | 2 | 0 |
| American Diagnostic Corp. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Bioprobe Intl., Inc. | 1 | 0 |
| Colony Laboratories, Inc. | 1 | 0 |
| ConvaTec, Inc | 0 | 1 |
| Hospitax | 1 | 0 |
| Innotron Diagnostics | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2016 | ConvaTec, Inc Nebulizer Masks Opti-Mist and Opti-Mist Clear
Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient. Terminated |
LCQ | K801867 |
| Feb 26, 2008 | Abbott Diagnostic International, Ltd. Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein trac Terminated |
LCQ | K801084 |
| Feb 26, 2008 | Abbott Diagnostic International, Ltd. Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and Terminated |
LCQ | K801084 |
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