FDA 510(k) Application Details - K023947

Device Classification Name	Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae   More FDA Info for this Device
510(K) Number	K023947
Device Name	Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
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	866.3390   More FDA Info for this Regulation Number
Classification Product Code	LIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2002
Decision Date	04/17/2003
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