FDA 510(k) Application Details - K052549

Device Classification Name	Lead, Atomic Absorption   More FDA Info for this Device
510(K) Number	K052549
Device Name	Lead, Atomic Absorption
Applicant	ESA BIOSCIENCES INC. 22 ALPHA RD. CHELMSFORD, MA 01824-4171 US Other 510(k) Applications for this Company
Contact	HAROLD ASP 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	09/16/2005
Decision Date	10/06/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review