FDA 510(k) Application Details - K962890

Device Classification Name	Enzymatic Esterase--Oxidase, Cholesterol   More FDA Info for this Device
510(K) Number	K962890
Device Name	Enzymatic Esterase--Oxidase, Cholesterol
Applicant	TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	David Johnston 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	07/24/1996
Decision Date	09/27/1996
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