LeadCare Plus Blood Lead Testing System— 510(k) K142705

Substantially Equivalent

Magellan Diagnostics

FDA 510(k) clearance K142705 for LeadCare Plus Blood Lead Testing System, Substantially Equivalent on 2015-07-07. Applicant: Magellan Diagnostics.

Clearance details

Applicant: Magellan Diagnostics
Product code: Code DOF
Advisory panel: Clinical Toxicology
Date received: 2014-09-22
Decision date: 2015-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.