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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Herpes Simplex Virus Nucleic Acid Amplification Assay
510(k) Number K140198
Device Name IMDX HSV-1/2 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 Number866.3305
Classification Product Code
OQO  
Date Received01/27/2014
Decision Date 05/13/2014
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
Predetermined Change
Control Plan Authorized		 No
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