FDA 510(k) Application Details - K142705

Device Classification Name	Lead, Atomic Absorption   More FDA Info for this Device
510(K) Number	K142705
Device Name	Lead, Atomic Absorption
Applicant	Magellan Diagnostics 101 Billerica Ave. Bldg #4 North Billerica, MA 01862 US Other 510(k) Applications for this Company
Contact	Reba Daoust 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	09/22/2014
Decision Date	07/07/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review