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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 K042357
Device Name IDI-MRSA ASSAY
Applicant
INFECTIO DIAGNOSTIC (I.D.I.) INC.
13801 eck road
hydes,  MD  21082
Contact judith smith
Regulation Number866.1640
Classification Product Code
NQX  
Date Received08/31/2004
Decision Date 10/22/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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