K220494 is an FDA 510(k) clearance for the BreathID Hp Lab System, 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 June 23, 2022, 121 days after receiving the submission on February 22, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K220494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2022 |
| Decision Date | June 23, 2022 |
| Days to Decision | 121 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 |