510(k) K230901
K230901 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "Premier HpSA Flex (619096)". The FDA issued a decision of Substantially Equivalent on July 3, 2023. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2023
- Date Received
- March 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Helicobacter Pylori
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type