FDA 510(k) Application Details - K960850

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)   More FDA Info for this Device
510(K) Number	K960850
Device Name	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Applicant	BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	CAROLE STAMP 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	03/01/1996
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