FDA 510(k) Application Details - K955360

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus   More FDA Info for this Device
510(K) Number	K955360
Device Name	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant	INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	MART FRICK Other 510(k) Applications for this Contact
Regulation Number	866.3175   More FDA Info for this Regulation Number
Classification Product Code	LFZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/1995
Decision Date	07/22/1996
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