FDA 510(k) Application Details - K963938

Device Classification Name	Chromatographic/Fluorometric Method, Catecholamines   More FDA Info for this Device
510(K) Number	K963938
Device Name	Chromatographic/Fluorometric Method, Catecholamines
Applicant	ESA, INC. 22 ALPHA RD. CHELMSFORD, MA 01824-4171 US Other 510(k) Applications for this Company
Contact	JAMES MAYOL Other 510(k) Applications for this Contact
Regulation Number	862.1165   More FDA Info for this Regulation Number
Classification Product Code	CHQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/1996
Decision Date	12/26/1996
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