FDA 510(k) Application Details - K032188

Device Classification Name	Radioimmunoassay, Aldosterone   More FDA Info for this Device
510(K) Number	K032188
Device Name	Radioimmunoassay, Aldosterone
Applicant	NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO SAN CLEMENTE, CA 92673 US Other 510(k) Applications for this Company
Contact	JIMMY WONG Other 510(k) Applications for this Contact
Regulation Number	862.1045   More FDA Info for this Regulation Number
Classification Product Code	CJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2003
Decision Date	07/31/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review