Exalenz Bioscience , Ltd.
Medical device manufacturer in Modiin, IL.
5510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K193610 | BreathID Smart SystemMSQ · Special | 02/06/2020SE |
| K173777 | BreathID Hp Lab SystemMSQ · Traditional | 03/08/2018SE |
| K173772 | BreathID Hp SystemMSQ · Traditional | 03/08/2018SE |
| K162150 | BreathID Hp Lab SystemMSQ · Traditional | 10/31/2016SE |
| K130524 | Breathid HP SystemMSQ · Traditional | 05/22/2013SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0042-2012 | IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience…The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no… | 06/07/2011Terminated |