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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 K131584
Device Name IMDX FLU A/B AND RSV FOR ABBOTT M2000
Applicant
INTELLIGENT MEDICAL DEVICES, INC
180 CABOT ST.
BEVERLY,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
INTELLIGENT MEDICAL DEVICES, INC
180 CABOT ST.
BEVERLY,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received05/31/2013
Decision Date 08/21/2013
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
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