FDA 510(k) Application Details - K991894

Device Classification Name	Colorimetric Method, Triglycerides   More FDA Info for this Device
510(K) Number	K991894
Device Name	Colorimetric Method, Triglycerides
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	862.1705   More FDA Info for this Regulation Number
Classification Product Code	JGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/1999
Decision Date	05/24/2000
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