
Magellan Diagnostics
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LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM is an FDA 510(k)-cleared medical device (K123563) manufactured by Magellan Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 2013. Regulation: 8.