FDA 510(k) Application Details - K082001

Device Classification Name	Atomic Absorption, Lithium   More FDA Info for this Device
510(K) Number	K082001
Device Name	Atomic Absorption, Lithium
Applicant	DIAZYME LABORATORIES 12889 GREGG COURT POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	Abhijit Datta Other 510(k) Applications for this Contact
Regulation Number	862.3560   More FDA Info for this Regulation Number
Classification Product Code	JII Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2008
Decision Date	12/05/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review