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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 K971640
Device Name LEADCARE BLOOD LEAD TESTING SYSTEM
Applicant
ESA, INC.
22 ALPHA RD.
CHELMSFORD,  MA  01824 -4171
Applicant Contact JAMES MAYOL
Correspondent
ESA, INC.
22 ALPHA RD.
CHELMSFORD,  MA  01824 -4171
Correspondent Contact JAMES MAYOL
Regulation Number862.3550
Classification Product Code
DOF  
Date Received05/02/1997
Decision Date 09/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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