FDA 510(k) Application Details - K010878

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific   More FDA Info for this Device
510(K) Number	K010878
Device Name	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Applicant	DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. LOS ANGELES, CA 90045-5597 US Other 510(k) Applications for this Company
Contact	EDWARD M LEVINE 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	03/19/2001
Decision Date	04/18/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review