FDA 510(k) Application Details - K980354

Device Classification Name	Cryptosporidium Spp.   More FDA Info for this Device
510(K) Number	K980354
Device Name	Cryptosporidium Spp.
Applicant	TECHLAB, INC. 1861 PRATT DR., STE. 1030 BLACKSBURG, VA 24060-6364 US Other 510(k) Applications for this Company
Contact	DAVID M LYERLY, PH.D. 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	01/29/1998
Decision Date	05/18/1998
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