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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
Applicant Contact JAMES MAYOL
Correspondent
Esa, Inc.
22 Alpha Rd.
Chelmsford,  MA  01824
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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