FDA 510(k) Application Details - K952559

Device Classification Name	Assay, Erythropoietin   More FDA Info for this Device
510(K) Number	K952559
Device Name	Assay, Erythropoietin
Applicant	NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY SAN JUAN CAPISTRANO, CA 92690 US Other 510(k) Applications for this Company
Contact	DAVE D SMITH 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	06/02/1995
Decision Date	05/29/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review