510(k) K233541
K233541 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics, Ltd. for the device "ARCHITECT Active-B12 (Holotranscobalamin)". The FDA issued a decision of Substantially Equivalent on July 31, 2024. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Axis-Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2024
- Date Received
- November 3, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioassay, Vitamin B12
- Device Class
- Class II
- Regulation Number
- 862.1810
- Review Panel
- CH
- Submission Type