FDA 510(k) Application Details - K023397

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K023397
Device Name	Acid, Folic, Radioimmunoassay
Applicant	ABBOTT LABORATORIES 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064-6187 US Other 510(k) Applications for this Company
Contact	MARGARET PROCHNIAK Other 510(k) Applications for this Contact
Regulation Number	862.1295   More FDA Info for this Regulation Number
Classification Product Code	CGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2002
Decision Date	12/16/2002
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