510(k) K223317
K223317 is an FDA 510(k) premarket notification submitted by Abbott Ireland Diagnostics Division for the device "Alkaline Phosphatase2". The FDA issued a decision of Substantially Equivalent on July 21, 2023. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Abbott Ireland Diagnostics Division has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2023
- Date Received
- October 28, 2022
- Clearance Type
- Traditional
- 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