FDA 510(k) Application Details - K955627

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)   More FDA Info for this Device
510(K) Number	K955627
Device Name	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Applicant	BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. ROCKLAND, MA 02370 US Other 510(k) Applications for this Company
Contact	TERRY MCGOVERN Other 510(k) Applications for this Contact
Regulation Number	866.3120   More FDA Info for this Regulation Number
Classification Product Code	LJC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/1995
Decision Date	10/07/1996
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