FDA 510(k) Application Details - K980737

Device Classification Name	Assay, Erythropoietin   More FDA Info for this Device
510(K) Number	K980737
Device Name	Assay, Erythropoietin
Applicant	NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR SAN JUAN CAPISTRANO, CA 92675 US Other 510(k) Applications for this Company
Contact	JIMMY WONG Other 510(k) Applications for this Contact
Regulation Number	864.7250   More FDA Info for this Regulation Number
Classification Product Code	GGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/1998
Decision Date	03/23/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review