510(k) K223179
K223179 is an FDA 510(k) premarket notification submitted by Alere San Diego, Inc. for the device "Cholestech LDX System". The FDA issued a decision of Substantially Equivalent on September 20, 2023. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2023
- Date Received
- October 11, 2022
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type