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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 K052549
Device Name LEADCARE II BLOOD LEAD TESTING SYSTEM
Applicant
ESA BIOSCIENCES INC.
22 ALPHA RD.
CHELMSFORD,  MA  01824 -4171
Applicant Contact HAROLD ASP
Correspondent
ESA BIOSCIENCES INC.
22 ALPHA RD.
CHELMSFORD,  MA  01824 -4171
Correspondent Contact HAROLD ASP
Regulation Number862.3550
Classification Product Code
DOF  
Date Received09/16/2005
Decision Date 10/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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