FDA 510(k) Application Details - K051444

Device Classification Name	Colorimetry, Cholinesterase   More FDA Info for this Device
510(K) Number	K051444
Device Name	Colorimetry, Cholinesterase
Applicant	SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO MILANO 20155 IT Other 510(k) Applications for this Company
Contact	DAVIDE SPADA Other 510(k) Applications for this Contact
Regulation Number	862.3240   More FDA Info for this Regulation Number
Classification Product Code	DIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2005
Decision Date	06/20/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review