FDA 510(k) Application Details - K963645

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific   More FDA Info for this Device
510(K) Number	K963645
Device Name	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Applicant	ARMKEL, LLC. 1306F BAILES LN. FREDERICK, MD 21701 US Other 510(k) Applications for this Company
Contact	WILLIAM L BOTELER, JR. 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	09/12/1996
Decision Date	02/04/1997
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