FDA 510(k) Application Details - K000270

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K000270
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	PRISCILLA A HAMMILL Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2000
Decision Date	03/07/2000
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