FDA 510(k) Applications for Medical Device Product Code "DOF"
(Lead, Atomic Absorption)

FDA 510(k) Number Applicant Device Name Decision Date
K052549 ESA BIOSCIENCES INC. LEADCARE II BLOOD LEAD TESTING SYSTEM 10/06/2005
K971640 ESA, INC. LEADCARE BLOOD LEAD TESTING SYSTEM 09/09/1997
K123563 MAGELLAN DIAGNOSTICS LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM 08/20/2013
K142705 Magellan Diagnostics LeadCare Plus Blood Lead Testing System 07/07/2015
K936060 THERMO JARRELL ASH CORP.DIV.THERMO INST. ATOMSPEC GF BLOOD LEAD WORKSTATION 09/06/1994
K843839 TRI-TECH, INC. STAT/PB REAGENT 01/03/1985


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