FDA 510(k) Application Details - K002651

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K002651
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. LINCOLN PARK, MI 48146 US Other 510(k) Applications for this Company
Contact	RON JAMISON Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2000
Decision Date	10/13/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review