FDA 510(k) Application Details - K021793

Device Classification Name	Epstein-Barr Virus, Other   More FDA Info for this Device
510(K) Number	K021793
Device Name	Epstein-Barr Virus, Other
Applicant	PAN BIO PTY. LTD. 116 LUTWYCHE RD. WINDSOR BRISBANE, QUEENSLAND 4030 AU Other 510(k) Applications for this Company
Contact	HELEN JENNINGS Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	LSE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2002
Decision Date	09/27/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review