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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,  CA G1V 2K8
Applicant Contact CHRISTIAN CHOQUET
Correspondent
INFECTIO DIAGNOSTIC (I.D.I.) INC.
2050 BOUL RENE-LEVESQUE O
4 IEME ETAGE
SAINTE-FOY,  CA G1V 2K8
Correspondent Contact CHRISTIAN CHOQUET
Regulation Number866.1640
Classification Product Code
NQX  
Date Received10/27/2003
Decision Date 03/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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