510(k) K240468
K240468 is an FDA 510(k) premarket notification submitted by Abbott Laboratories Diagnostics Division for the device "Alkaline Phosphatase". The FDA issued a decision of Substantially Equivalent on October 16, 2024. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Abbott Laboratories Diagnostics Division has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2024
- Date Received
- February 20, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type