FDA 510(k) Application Details - K041657

Device Classification Name	Radioassay, Angiotensin Converting Enzyme   More FDA Info for this Device
510(K) Number	K041657
Device Name	Radioassay, Angiotensin Converting Enzyme
Applicant	THERMO ELECTRON CORPORATION 331 SOUTH 104TH STREET LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	BOLA NICHOLSON Other 510(k) Applications for this Contact
Regulation Number	862.1090   More FDA Info for this Regulation Number
Classification Product Code	KQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2004
Decision Date	08/30/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review