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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lead, Atomic Absorption
510(k) Number K123563
Device Name LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
Applicant
Magellan Diagnostics
101 Billerica Ave., Bldg. 4
N. Billerica,  MA  01862
Applicant Contact STUART NAYLOR
Correspondent
Magellan Diagnostics
101 Billerica Ave., Bldg. 4
N. Billerica,  MA  01862
Correspondent Contact STUART NAYLOR
Regulation Number862.3550
Classification Product Code
DOF  
Date Received11/19/2012
Decision Date 08/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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