FDA 510(k) Application Details - K011970

Device Classification Name	Enzymatic Esterase--Oxidase, Cholesterol   More FDA Info for this Device
510(K) Number	K011970
Device Name	Enzymatic Esterase--Oxidase, Cholesterol
Applicant	BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 LAKE FOREST, IL 60045 US Other 510(k) Applications for this Company
Contact	JACK A MAGGIORE 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	06/25/2001
Decision Date	09/26/2001
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