510(k) K142362
K142362 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2014
- Date Received
- August 25, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Vitamin D
- Device Class
- Class II
- Regulation Number
- 862.1825
- Review Panel
- CH
- Submission Type