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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K091667
Device Name XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
TORONTO, ONTARIO,  CA M5G 1Y8
Applicant Contact GLORIA LEE
Correspondent
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
TORONTO, ONTARIO,  CA M5G 1Y8
Correspondent Contact GLORIA LEE
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP  
Date Received06/09/2009
Decision Date 06/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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