FDA 510(k) Application Details - K993377

Device Classification Name	Lipoprotein, High Density, Hdl, Over The Counter   More FDA Info for this Device
510(K) Number	K993377
Device Name	Lipoprotein, High Density, Hdl, Over The Counter
Applicant	POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	MARGO ENRIGHT Other 510(k) Applications for this Contact
Regulation Number	862.1175   More FDA Info for this Regulation Number
Classification Product Code	NAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/1999
Decision Date	01/13/2000
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