Panels › Microbiology › Product code MSQ · Class 1
Test, Urea (Breath Or Blood)
Regulation 866.3110
0510(k)s in 12 months (17 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in MSQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Exalenz Bioscience , Ltd. | 5 | 1 |
| Meretek Diagnostics, Inc. | 2 | 1 |
| Meridian Bioscience Israel , Ltd. | 3 | 0 |
| Otsuka Pharmaceutical Co., Ltd. | 2 | 0 |
| Alimenterics, Inc. | 1 | 0 |
| Hema Metrics, LLC | 1 | 0 |
| Meretek | 1 | 0 |
| Metabolic Solutions, Inc. | 1 | 0 |
| Oridion Medical 1987 , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2011 | Exalenz Bioscience Ltd IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100 Terminated |
MSQ | None listed |
| Oct 4, 2007 | Meretek Diagnostics, Inc. BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO. Terminated |
MSQ | K014225 |
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