FDA 510(k) Application Details - K070987

Device Classification Name	Assay, Porphyrin, Spectrophotometry, Lithium   More FDA Info for this Device
510(K) Number	K070987
Device Name	Assay, Porphyrin, Spectrophotometry, Lithium
Applicant	SENTINEL CH SPA VIA ROBERT KOCH 2 MILAN 20152 IT Other 510(k) Applications for this Company
Contact	FABIO ROTA Other 510(k) Applications for this Contact
Regulation Number	862.3560   More FDA Info for this Regulation Number
Classification Product Code	NDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2007
Decision Date	08/02/2007
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