FDA 510(k) Application Details - K983704

Device Classification Name	Control, Hemoglobin, Abnormal   More FDA Info for this Device
510(K) Number	K983704
Device Name	Control, Hemoglobin, Abnormal
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 SOMERVILLE, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	RITA SMITH Other 510(k) Applications for this Contact
Regulation Number	864.7415   More FDA Info for this Regulation Number
Classification Product Code	JCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/1998
Decision Date	02/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review