FDA 510(k) Application Details - K984108

Device Classification Name	Radioassay, Intrinsic Factor Blocking Antibody   More FDA Info for this Device
510(K) Number	K984108
Device Name	Radioassay, Intrinsic Factor Blocking Antibody
Applicant	ABBOTT LABORATORIES 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	LAURA L GRANITZ Other 510(k) Applications for this Contact
Regulation Number	862.1810   More FDA Info for this Regulation Number
Classification Product Code	LIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/1998
Decision Date	02/03/1999
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