K223185 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 Meridian Bioscience Israel , Ltd. (Modiin, IL). The FDA issued a Cleared decision on November 10, 2022, 29 days after receiving the submission on October 12, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K223185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2022 |
| Decision Date | November 10, 2022 |
| Days to Decision | 29 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 |