FDA 510(k) Application Details - K002024

Device Classification Name	Antigens, All, Leptospira Spp.   More FDA Info for this Device
510(K) Number	K002024
Device Name	Antigens, All, Leptospira Spp.
Applicant	PANBIO, INC. 605 DILWORTH RD. DOWNINGTOWN, PA 19335 US Other 510(k) Applications for this Company
Contact	DAVID C BISHOP Other 510(k) Applications for this Contact
Regulation Number	866.3350   More FDA Info for this Regulation Number
Classification Product Code	GRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2000
Decision Date	11/22/2000
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