FDA 510(k) Application Details - K031965

Device Classification Name	Cryptosporidium Spp.   More FDA Info for this Device
510(K) Number	K031965
Device Name	Cryptosporidium Spp.
Applicant	REMEL INC 1400 UNITY ST. NORTHWEST RAMSEY, MN 55303 US Other 510(k) Applications for this Company
Contact	RICHARD TYSON Other 510(k) Applications for this Contact
Regulation Number	866.3220   More FDA Info for this Regulation Number
Classification Product Code	MHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2003
Decision Date	11/14/2003
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