510(k) K142705
K142705 is an FDA 510(k) premarket notification submitted by Magellan Diagnostics for the device "LeadCare Plus Blood Lead Testing System". The FDA issued a decision of Substantially Equivalent on July 7, 2015. The device falls under product code DOF (Lead, Atomic Absorption), a Class II device regulated under 21 CFR 862.3550. Magellan Diagnostics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2015
- Date Received
- September 22, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lead, Atomic Absorption
- Device Class
- Class II
- Regulation Number
- 862.3550
- Review Panel
- TX
- Submission Type