FDA 510(k) Application Details - K123563

Device Classification Name	Lead, Atomic Absorption   More FDA Info for this Device
510(K) Number	K123563
Device Name	Lead, Atomic Absorption
Applicant	MAGELLAN DIAGNOSTICS 101 BILLERICA AVE. BLDG #4 NORTH BILLERICA, MA 01862-1271 US Other 510(k) Applications for this Company
Contact	STUART NAYLOR Other 510(k) Applications for this Contact
Regulation Number	862.3550   More FDA Info for this Regulation Number
Classification Product Code	DOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2012
Decision Date	08/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review