FDA 510(k) Application Details - K981306

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific   More FDA Info for this Device
510(K) Number	K981306
Device Name	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Applicant	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US Other 510(k) Applications for this Company
Contact	LYNNE STIRLING Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	LGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/1998
Decision Date	09/29/1998
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