FDA 510(k) Application Details - K013919

Device Classification Name	Fab, Rhodamine, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K013919
Device Name	Fab, Rhodamine, Antigen, Antiserum, Control
Applicant	BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 MISSISSAUGA, ONTARIO L4W-4T7 CA Other 510(k) Applications for this Company
Contact	KRIS SHAH Other 510(k) Applications for this Contact
Regulation Number	866.5520   More FDA Info for this Regulation Number
Classification Product Code	DBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2001
Decision Date	02/22/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review