FDA 510(k) Application Details - K022519

Device Classification Name	Colorimetric Method, Lipoproteins   More FDA Info for this Device
510(K) Number	K022519
Device Name	Colorimetric Method, Lipoproteins
Applicant	JAS Diagnostics, Inc. 7220 NW 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	David Johnston Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	JHM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2002
Decision Date	09/30/2002
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