K193610 is an FDA 510(k) clearance for the BreathID Smart System. This device is classified as a Test, Urea (breath Or Blood) (Class I - General Controls, product code MSQ).
Submitted by Exalenz Bioscience , Ltd. (Modiin, IL). The FDA issued a Cleared decision on February 6, 2020, 42 days after receiving the submission on December 26, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K193610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2019 |
| Decision Date | February 06, 2020 |
| Days to Decision | 42 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MSQ — Test, Urea (breath Or Blood) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |