FDA 510(k) Application Details - K023208

Device Classification Name	Cyclosporine   More FDA Info for this Device
510(K) Number	K023208
Device Name	Cyclosporine
Applicant	MICROGENICS CORP. 46360 FREMONT BLVD. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	MARK HAMILTON SMITH Other 510(k) Applications for this Contact
Regulation Number	862.1235   More FDA Info for this Regulation Number
Classification Product Code	MKW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2002
Decision Date	10/24/2002
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	N
Expedited Review