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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 K142705
Device Name LeadCare Plus Blood Lead Testing System
Applicant
Magellan Diagnostics
101 Billerica Ave., Bldg. 4
N. Billerica,  MA  01862
Applicant Contact Reba Daoust
Correspondent
Magellan Diagnostics
101 Billerica Ave., Bldg. 4
N. Billerica,  MA  01862
Correspondent Contact Reba Daoust
Regulation Number862.3550
Classification Product Code
DOF  
Date Received09/22/2014
Decision Date 07/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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