LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM— 510(k) K123563

Substantially Equivalent

Magellan Diagnostics

FDA 510(k) clearance K123563 for LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM, Substantially Equivalent on 2013-08-20. Applicant: Magellan Diagnostics.

Clearance details

Applicant: Magellan Diagnostics
Product code: Code DOF
Advisory panel: Clinical Toxicology
Date received: 2012-11-19
Decision date: 2013-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Billerica, MA, US

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