FDA 510(k) Application Details - K001032

Device Classification Name	Enzymatic Esterase--Oxidase, Cholesterol   More FDA Info for this Device
510(K) Number	K001032
Device Name	Enzymatic Esterase--Oxidase, Cholesterol
Applicant	OTSUKA PHARMACEUTICAL CO., LTD. 2440 RESEARCH BLVD. ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	JAMES W HARRIS Other 510(k) Applications for this Contact
Regulation Number	862.1175   More FDA Info for this Regulation Number
Classification Product Code	CHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2000
Decision Date	07/24/2000
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