FDA 510(k) Application Details - K992002

Device Classification Name	Ldl & Vldl Precipitation, Hdl   More FDA Info for this Device
510(K) Number	K992002
Device Name	Ldl & Vldl Precipitation, Hdl
Applicant	POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. LINCOLN PARK, MI 48146 US Other 510(k) Applications for this Company
Contact	WILLIAM F WALTERS Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	LBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/1999
Decision Date	08/05/1999
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