FDA 510(k) Application Details - K023860

Device Classification Name	Albumin, Fitc, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K023860
Device Name	Albumin, Fitc, Antigen, Antiserum, 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	866.5040   More FDA Info for this Regulation Number
Classification Product Code	DDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2002
Decision Date	04/28/2003
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