FDA 510(k) Application Details - K981865

Device Classification Name	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase   More FDA Info for this Device
510(K) Number	K981865
Device Name	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
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	862.1380   More FDA Info for this Regulation Number
Classification Product Code	JMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/1998
Decision Date	02/26/1999
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