FDA 510(k) Application Details - K972853

Device Classification Name	Enzymatic Esterase--Oxidase, Cholesterol   More FDA Info for this Device
510(K) Number	K972853
Device Name	Enzymatic Esterase--Oxidase, Cholesterol
Applicant	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111-1203 US Other 510(k) Applications for this Company
Contact	DANIEL C WEYKER 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	06/27/1997
Decision Date	09/24/1997
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