Submission Details
| 510(k) Number | K142705 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 22, 2014 |
| Decision Date | July 07, 2015 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
LeadCare Plus Blood Lead Testing System
Jul 2015
Decision
288d
Days
Class 2
Risk
About This 510(k) Submission
K142705 is an FDA 510(k) clearance for the LeadCare Plus Blood Lead Testing System, a Lead, Atomic Absorption (Class II — Special Controls, product code DOF), submitted by Magellan Diagnostics (N. Billerica, US). The FDA issued a Cleared decision on July 7, 2015, 288 days after receiving the submission on September 22, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3550.
Device Classification
| Product Code | DOF — Lead, Atomic Absorption |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3550 |
Manufacturer
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