FDA 510(k) Application Details - K992188

Device Classification Name	Immunochemical, Transferrin   More FDA Info for this Device
510(K) Number	K992188
Device Name	Immunochemical, Transferrin
Applicant	NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR SAN JUAN CAPISTRANO, CA 92675 US Other 510(k) Applications for this Company
Contact	JAMES A RYBSKI Other 510(k) Applications for this Contact
Regulation Number	866.5880   More FDA Info for this Regulation Number
Classification Product Code	JNM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/1999
Decision Date	12/06/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review