FDA 510(k) Application Details - K012287

Device Classification Name	System, Test, Low Density, Lipoprotein   More FDA Info for this Device
510(K) Number	K012287
Device Name	System, Test, Low Density, Lipoprotein
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	SHERRI L COENEN Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	MRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2001
Decision Date	08/07/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review