510(k) K223185
K223185 is an FDA 510(k) premarket notification submitted by Meridian Bioscience Israel , Ltd. for the device "BreathID® Smart System". The FDA issued a decision of Substantially Equivalent on November 10, 2022. The device falls under product code MSQ (Test, Urea (Breath Or Blood)), a Class I device regulated under 21 CFR 866.3110. Meridian Bioscience Israel , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2022
- Date Received
- October 12, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Urea (Breath Or Blood)
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type