Company ยท IL
Exalenz Bioscience , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2020. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MSQ | Test, Urea (Breath Or Blood) | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2020 | K193610 | BreathID Smart System Exalenz Bioscience , Ltd., IL | MSQ |
| Mar 8, 2018 | K173777 | BreathID Hp Lab System Exalenz Bioscience , Ltd., IL | MSQ |
| Mar 8, 2018 | K173772 | BreathID Hp System Exalenz Bioscience , Ltd., IL | MSQ |
| Oct 31, 2016 | K162150 | BreathID Hp Lab System Exalenz Bioscience , Ltd., IL | MSQ |
| May 22, 2013 | K130524 | BREATHID HP SYSTEM Exalenz Bioscience , Ltd. | MSQ |
Latest recalls
| 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 |