510(k) K182012
K182012 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics Limited for the device "ADVIA Centaur Calcitonin (CALCT) assay". The FDA issued a decision of Substantially Equivalent on December 21, 2018. The device falls under product code JKR (Radioimmunoassay, Calcitonin), a Class II device regulated under 21 CFR 862.1140. Axis-Shield Diagnostics Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2018
- Date Received
- July 27, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Calcitonin
- Device Class
- Class II
- Regulation Number
- 862.1140
- Review Panel
- CH
- Submission Type