FDA 510(k) Application Details - K955904

Device Classification Name	System, Test, Low Density, Lipoprotein   More FDA Info for this Device
510(K) Number	K955904
Device Name	System, Test, Low Density, Lipoprotein
Applicant	JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. ROCHESTER, NY 14650-0882 US Other 510(k) Applications for this Company
Contact	CHARLES C MORGANSON, JR. 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	12/29/1995
Decision Date	05/24/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review