FDA 510(k) Application Details - K033415

Device Classification Name	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen   More FDA Info for this Device
510(K) Number	K033415
Device Name	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Applicant	INFECTIO DIAGNOSTIC (I.D.I.) INC. 2050 BOUL RENE-LEVESQUE O 4 IEME ETAGE SAINTE-FOY G1V 2K8 CA Other 510(k) Applications for this Company
Contact	CHRISTIAN CHOQUET Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2003
Decision Date	03/18/2004
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