FDA 510(k) Application Details - K032330

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)   More FDA Info for this Device
510(K) Number	K032330
Device Name	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Applicant	THERMO BIOSTAR, INC. 331 SOUTH 104TH ST. LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	JOHN G ADAMS 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	07/29/2003
Decision Date	03/02/2004
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