LEADCARE II BLOOD LEAD TESTING SYSTEM— 510(k) K052549

Substantially Equivalent

Esa Biosciences, Inc.

FDA 510(k) clearance K052549 for LEADCARE II BLOOD LEAD TESTING SYSTEM, Substantially Equivalent on 2005-10-06. Applicant: Esa Biosciences, Inc..

Clearance details

Applicant: Esa Biosciences, Inc.
Product code: Code DOF
Advisory panel: Clinical Toxicology
Date received: 2005-09-16
Decision date: 2005-10-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelmsford, MA, US

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