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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
510(K) Number K033415
Device Name IDI-MRSA
Applicant
INFECTIO DIAGNOSTIC (I.D.I.) INC.
2050 boul rene-levesque o
4 ieme etage
sainte-foy, 
Contact christian choquet
Regulation Number866.1640
Classification Product Code
NQX  
Date Received10/27/2003
Decision Date 03/18/2004
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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