FDA 510(k) Application Details - K960785

Device Classification Name	Electrophoretic Separation, Lipoproteins   More FDA Info for this Device
510(K) Number	K960785
Device Name	Electrophoretic Separation, Lipoproteins
Applicant	ZAXIS, INC. 1890 GEORGETOWN RD. HUDSON, OH 44236 US Other 510(k) Applications for this Company
Contact	KENNETH W EGGER Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	JHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/1996
Decision Date	09/03/1996
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